Flucelvax Quadrivalent Side Effects
Generic name: influenza virus vaccine, inactivated
Medically reviewed by Drugs.com. Last updated on May 29, 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 Flucelvax Quadrivalent.
Applies to influenza virus vaccine, inactivated: suspension. Other dosage forms:
In 1976, a number of people who received the “swine flu” influenza vaccine developed Guillain-Barré syndrome (GBS), which is a disease that may cause paralysis. Most of these people were over 25 years of age. Although only 10 out of every one million people who received the vaccine actually developed GBS, this number was 6 times higher than would normally have been expected. Most of the people who got GBS recovered completely.
It is assumed that the “swine flu” virus included in the 1976 vaccine caused the problem, but this has not been proven. Since that time, studies have shown that the risk of acquiring GBS from an influenza vaccine is very low (one out of every million people).
Serious side effects
Along with its needed effects, influenza virus vaccine, inactivated (the active ingredient contained in Flucelvax 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:
More common
- Bruising, hard lump, redness, or pain at the injection site
- cough
- diarrhea
- fever
- headache
- irritability
- large, flat, blue or purplish patches in the skin
- loss of appetite
- muscle aches
- redness of the eyes
- sneezing
- sore throat
- stuffy or runny nose
- vomiting
Less common
- Body aches or pain
- chest tightness
- chills
- difficulty with breathing
- earache
- ear congestion
- loss of voice
- shivering
- swelling or puffiness of the face
- unusual tiredness or weakness
Rare
- Difficulty with swallowing
- dizziness
- fast heartbeat
- hives, itching, or skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- noisy breathing
- puffiness or swelling of the eyelids or around the eyes, lips, or tongue
Incidence not known
- Agitation
- back pain, sudden and severe
- back, leg, or stomach pains
- blistering, peeling, or loosening of the skin
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- burning, dry, or itching eyes
- chest pain
- clumsiness or unsteadiness
- confusion
- drowsiness
- dryness of the throat
- fainting
- feeling hot
- increased sensitivity of the eyes to sunlight
- inflammation, rash, swelling, or tenderness at the injection site
- lightheadedness
- nosebleeds
- pain, redness, soreness, swelling, tenderness, or warmth on the skin
- pinpoint red spots on the skin
- redness of the face, neck, arms, and occasionally, upper chest
- sensation of spinning
- shakiness in the legs, arms, hands, or feet
- sores, ulcers, or white spots in the mouth or on the lips
- sores, welts, or blisters
- stomach pain, soreness, or discomfort
- sweating
- trouble sleeping
- unusual bleeding or bruising
- voice changes
- weakness of the muscles in your face
- yellowing of the eyes or skin
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
- Difficulty in moving
- joint pain
- muscle aches, cramping, pains, or stiffness
- swollen joints
Incidence not known
- Sleepiness or unusual drowsiness
For Healthcare Professionals
Applies to influenza virus vaccine, inactivated: intradermal suspension, intramuscular solution, intramuscular suspension, nasal spray.
General
The most common adverse events occurring in greater than 30% of patients (inclusive of all age groups) were local injection site reactions, myalgia, headache, drowsiness/sleepiness, malaise, pain, and abnormal crying.[Ref]
Cardiovascular
Rare (0.01% to 0.1%): Flushing, hot flush
Postmarketing reports: Vasculitis which may be associated with transient renal involvement, vasodilatation, pallor, tachycardia, Henoch-Schonlein purpura
Dermatologic
Common (1% to 10%): Sweating
Rare (0.01% to 0.1%): Pruritus, urticaria, night sweats, rash
Postmarketing reports: Stevens-Johnson syndrome, erythema multiforme, erythema, angioedema, cellulitis, local or generalized non-specific rash
Gastrointestinal
Very common (10% or more): Diarrhea (up to 23.2%), vomiting (up to 10.5%)
Common (1% to 10%): Nausea
Frequency not reported: Gastroenteritis
Postmarketing reports: Abdominal pain, dysphagia, swelling of the mouth, throat, and/or tongue
Hematologic
Uncommon (0.1% to 1%): Lymphadenopathy
Postmarketing reports: Thrombocytopenia
Hypersensitivity
Uncommon (0.1% to 1%): Hypersensitivity
Rare (0.01% to 0.1%): Allergic reactions
Postmarketing reports: Anaphylaxis/anaphylactoid reaction, allergic reactions, and other forms of hypersensitivity such as shock, serum sickness, and angioedema
Local
Very common (10% or more): Injection site pain (up to 66.6%), injection site tenderness (up to 54.1%), injection site erythema (up to 37.3%), injection site itching (up to 28%), injection site swelling/lump (up to 25.9%), injection site induration (up to 17.7%), injection site ecchymosis (up to 11.2%)
Common (1% to 10%): Injection site bruising
Uncommon (0.1% to 1%): Injection site warmth
Rare (0.01% to 0.1%): Injection site discomfort
Postmarketing reports: Injection site cellulitis-like reaction, injection site sterile abscess, injection site reaction[Ref]
Musculoskeletal
Very common (10% or more): Myalgia (up to 38.6%), muscle aches (up to 29%), arthralgia (up to 13%)
Uncommon (0.1% to 1%): Muscular weakness
Postmarketing reports: Arthritis
Nervous system
Very common (10% or more): Drowsiness (up to 37.7%), sleepiness (up to 35.5%), headache (up to 27.8%)
Uncommon (0.1% to 1%): Lethargy
Rare (0.01% to 0.1%): Dizziness, paresthesia, somnolence
Postmarketing reports: Guillain-Barre syndrome (GBS), convulsions/seizures, febrile convulsions, myelitis, encephalomyelitis, transverse myelitis, facial palsy (Bell's palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), hypoesthesia, hypokinesia, tremor, syncope, facial or cranial nerve paralysis, encephalopathy, limb paralysis
Ocular
Rare (0.01% to 0.1%): Ocular hyperemia
Postmarketing reports: Eye pain, photophobia, conjunctivitis, eye irritation, eye redness, eye swelling, eyelid swelling
Other
Very common (10% or more): Pain (up to 59%), abnormal crying (up to 41.2%), malaise (up to 38.1%), change of eating habits (21%), fatigue (up to 22%), loss of appetite (up to 16%)
Common (1% to 10%): Shivering, fever, influenza-like symptoms
Rare (0.01% to 0.1%): Vertigo, asthenia
Frequency not reported: Varicella
Postmarketing reports: Chest pain, chills, extensive swelling of injected limb, peripheral swelling, abnormal gait, pain in extremity, feeling hot, body aches
Psychiatric
Very common (10% or more): Irritability/fussiness (up to 54%)
Uncommon (0.1% to 1%): Moaning, restlessness
Postmarketing reports: Insomnia
Respiratory
Uncommon (0.1% to 1%): Cough, oropharyngeal pain
Rare (0.01% to 0.1%): Rhinorrhea
Postmarketing reports: Dyspnea, cough, wheezing, throat tightness, rhinitis, tonsillitis, laryngitis, dysphonia, bronchospasm, asthma, croup
Frequently asked questions
- How and where is a flu shot injection given?
- What flu vaccine can I use with an egg allergy?
- 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 Flucelvax Quadrivalent (influenza virus vaccine, inactivated)
- Check interactions
- Compare alternatives
- Reviews (1)
- Dosage information
- During pregnancy
- Drug class: viral vaccines
Patient resources
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References
1. (2023) "Product Information. Fluarix Tetra 2024 (influenza virus vaccine, inactivated)." GlaxoSmithKline Australia Pty Ltd, 16.0
2. (2023) "Product Information. Fluquadri 2024 (influenza virus vaccine, inactivated)." Sanofi-Aventis Australia Pty Ltd
3. (2019) "Product Information. Fluad Quad 2024 with Attached Needle (influenza virus vaccine, inactivated)." Seqirus Pty Ltd
4. (2023) "Product Information. Flucelvax Quad 2024 with Needle (influenza virus vaccine, inactivated)." Seqirus Pty Ltd
5. (2023) "Product Information. Fluzone High-Dose 2024 with Needle (influenza virus vaccine, inactivated)." Sanofi-Aventis Australia Pty Ltd
6. (2023) "Product Information. Influvac Tetra 2024 (influenza virus vaccine, inactivated)." Viatris Pty Ltd
7. (2023) "Product Information. Afluria Quad 2024 with Attached Needle (influenza virus vaccine, inactivated)." Seqirus Pty Ltd
8. (2023) "Product Information. Vaxigrip Tetra 2024 (influenza virus vaccine, inactivated)." Sanofi-Aventis Australia Pty Ltd
9. (2023) "Product Information. Afluria PF Quadrivalent 2023-2024 (influenza virus vaccine, inactivated)." Seqirus, A CSL Company
10. (2023) "Product Information. Fluarix PF Quadrivalent 2023-2024 (influenza virus vaccine, inactivated)." GlaxoSmithKline
11. (2023) "Product Information. Flublok Quadrivalent 2023-2024 (influenza virus vaccine, inactivated)." sanofi pasteur
12. (2023) "Product Information. Flucelvax Quadrivalent 2023-2024 (influenza virus vaccine, inactivated)." Seqirus, A CSL Company
13. (2023) "Product Information. FluLaval PF Quadrivalent 2023-2024 (influenza virus vaccine, inactivated)." ID Biomedical Corp
14. (2023) "Product Information. Fluzone PF Quadrivalent 2023-2024 (influenza virus vaccine, inactivated)." sanofi pasteur
15. (2023) "Product Information. Fluzone High-Dose Quadrivalent PF 2023-2024 (influenza virus vaccine, inactivated)." sanofi pasteur
16. (2023) "Product Information. Influenza (Split Virion, Inactivated) Vaccine (influenza vaccine)." Sanofi Pasteur
17. (2023) "Product Information. Cell-Based Quadrivalent Influenza Vaccine (influenza vaccine)." Seqirus UK Ltd
18. (2023) "Product Information. Supemtek Quadrivalent (influenza vaccine)." Sanofi
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.