Afluria Preservative-Free Pediatric Quadrivalent Side Effects
Generic name: influenza virus vaccine, inactivated
Medically reviewed by Drugs.com. Last updated on Aug 10, 2024.
Note: This document provides detailed information about Afluria Preservative-Free Pediatric Quadrivalent Side Effects associated with influenza virus vaccine, inactivated. Some dosage forms listed on this page may not apply specifically to the brand name Afluria Preservative-Free Pediatric Quadrivalent.
Applies to influenza virus vaccine, inactivated: intramuscular emulsion.
Other dosage forms:
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
- headache
- joint or muscle pain
- pain at the injection site
Less common
- diarrhea
- loss of appetite
- nausea or vomiting
- redness or swelling at the injection site
Serious side effects
Along with its needed effects, influenza virus vaccine, inactivated (the active ingredient contained in Afluria Preservative-Free Pediatric 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:
Less common
- fever or chills
Incidence not known
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- cough
- difficulty swallowing
- dizziness
- fainting
- fast heartbeat
- hives, itching, or rash
- inability to move the arms and legs
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- sudden numbness and weakness in the arms and legs
- tightness in the chest
- unusual bleeding or bruising
- unusual tiredness or weakness
For healthcare professionals
Applies to influenza virus vaccine, inactivated: intradermal suspension, intramuscular solution, intramuscular suspension, nasal spray.
General
The most commonly reported side (inclusive of all age groups) were local injection site reactions, myalgia, headache, drowsiness/sleepiness, malaise, pain, and abnormal crying.[Ref]
Cardiovascular
- Common (1% to 10%): Chest tightness
- Rare (0.01% to 0.1%): Flushing/vasodilation, hot flush
- Frequency not reported: Myocarditis
- Postmarketing reports: chest pain, extensive swelling of injected limb, Henoch-Schonlein purpura, pallor, tachycardia, vasculitis (with potential transient renal involvement)[Ref]
Dermatologic
- Common (1% to 10%): Facial swelling, rash, sweating
- Rare (0.01% to 0.1%): Pruritus, night sweats, urticaria
- Frequency not reported: Cellulitis-like reactions, erythema multiforme
- Postmarketing reports: Angioedema, cellulitis, erythema, generalized rash, generalized skin reactions, localized rash, non-specific rash (local/generalized), Stevens-Johnson syndrome[Ref]
Gastrointestinal
- Very common (10% or more): Diarrhea (up to 25.6%), vomiting (up to 14.8%), nausea (up to 11%)
- Common (1% to 10%): Oropharyngeal pain, teething
- Uncommon (0.1% to 1%): Upper abdominal pain
- Frequency not reported: Gastroenteritis
- Postmarketing reports: Abdominal pain, dysphagia, swelling of the mouth, throat, and/or tongue[Ref]
Hematologic
- Uncommon (0.1% to 1%): Lymphadenopathy
- Postmarketing reports: Thrombocytopenia[Ref]
Hypersensitivity
- Uncommon (0.1% to 1%): Hypersensitivity
- Rare (0.01% to 0.1%): Allergic reactions
- Postmarketing reports: Anaphylactic shock, anaphylaxis, immediate hypersensitivity reactions, other allergic reactions, other hypersensitivity reactions, serum sickness, shock[Ref]
Immunologic
- Common (1% to 10%): Influenza-like illness
- Frequency not reported: Influenza B infection (vaccine failure), Varicella[Ref]
Local
- Very common (10% or more): Injection site tenderness (up to 89.4%), injection site pain (up to 66.6%), injection site swelling (up to 64.8%), injection site redness/erythema (up to 60.1%), injection site itching (up to 28%), injection site induration (up to 17.7%), injection site bruising/hematoma (up to 17.6%), injection site ecchymosis (up to 15.2%), injection site lump (up to 11%)
- Uncommon (0.1% to 1%): Injection site warmth
- Rare (0.01% to 0.1%): Injection site discomfort
- Postmarketing reports: Decreased injected limb mobility, injection site cellulitis-like reaction, injection site inflammation, injection site rash, injection site reaction, injection site sterile abscess, large injection site swelling[Ref]
Metabolic
- Very common (10% or more): Loss of appetite (up to 33.3%), eating habit changes (up to 21%)[Ref]
Musculoskeletal
- Very common (10% or more): Myalgia/musculoskeletal pain (up to 38.6%), muscle aches (up to 29%), arthralgia (up to 13%)
- Common (1% to 10%): Chills, shivering
- Uncommon (0.1% to 1%): Muscular/muscle weakness
- Frequency not reported: Myositis
- Postmarketing reports: Abnormal gait, arthritis, extremity pain[Ref]
Nervous system
- Very common (10% or more): Drowsiness (up to 37.7%), sleepiness (up to 35.5%), headache (up to 30.3%)
- Uncommon (0.1% to 1%): Lethargy, vertigo
- Rare (0.01% to 0.1%): Dizziness, paresthesia, somnolence
- Frequency not reported: Febrile seizures
- Postmarketing reports: Brachial neuritis, convulsions/seizures, cranial nerve paralysis, encephalitis, encephalomyelitis, encephalopathy, facial nerve paralysis/facial palsy/Bell's palsy, febrile convulsions, Guillain-Barre syndrome (GBS), hypoesthesia, hypokinesia, limb paralysis, myelitis, neuralgia, neuritis, neuropathy, presyncope, syncope (shortly after vaccination), transverse myelitis, tremor[Ref]
Ocular
- Common (1% to 10%): Otitis media, reddened eyes/eye redness
- Rare (0.01% to 0.1%): Ocular hyperemia
- Frequency not reported: Acute otitis media
- Postmarketing reports: Conjunctivitis, eye irritation, eye pain, eye swelling, eyelid swelling, optic neuritis/neuropathy, photophobia[Ref]
Other
- Very common (10% or more): Pain (up to 59%), malaise (up to 38.1%), fatigue (up to 22%), fever/pyrexia (16%)
- Common (1% to 10%): Ear infection
- Rare (0.01% to 0.1%): Asthenia
- Frequency not reported: Death
- Postmarketing reports: Body aches, feeling hot[Ref]
Psychiatric
- Very common (10% or more): Irritability (up to 54%), fussiness (up to 54%), abnormal crying (up to 41.2%)
- Uncommon (0.1% to 1%): Moaning, restlessness
- Postmarketing reports: Insomnia[Ref]
Respiratory
- Very common (10% or more): Rhinorrhea (up to 11.2%), cough (up to 10.4%)
- Common (1% to 10%): Croup infections/croup, nasal congestion, nasopharyngitis, sore throat, upper respiratory tract infection
- Frequency not reported: Bronchitis, bronchiolitis, pneumonia, pulmonary congestion, shortness of breath
- Postmarketing reports: Asthma, bronchospasm, dyspnea, dysphonia, laryngitis, rhinitis, throat tightness, tonsillitis, wheezing[Ref]
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
19. (2024) "Product Information. Afluria 2024-2025 (influenza virus vaccine, inactivated)." Seqirus, A CSL Company
20. (2024) "Product Information. Fluad PF Prefilled Syringe 2024-2025 (influenza virus vaccine, inactivated)." Seqirus, A CSL Company
21. (2024) "Product Information. Fluarix PF Prefilled Syringe 2024-2025 (influenza virus vaccine, inactivated)." GlaxoSmithKline
22. (2024) "Product Information. Flublok PF Prefilled Syringe 2024-2025 (influenza virus vaccine, inactivated)." sanofi pasteur
23. (2024) "Product Information. Flucelvax 2024-2025 (influenza virus vaccine, inactivated)." Seqirus, A CSL Company
24. (2024) "Product Information. FluLaval PF Prefilled Syringe 2024-2025 (influenza virus vaccine, inactivated)." ID Biomedical Corp
25. (2024) "Product Information. Fluzone 2024-2025 (influenza virus vaccine, inactivated)." sanofi pasteur
26. (2024) "Product Information. Fluzone High-Dose PF Prefilled Syringe 2024-2025 (influenza virus vaccine, inactivated)." sanofi pasteur
Frequently asked questions
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More about Afluria Preservative-Free Pediatric Quadrivalent (influenza virus vaccine, inactivated)
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- Dosage information
- During pregnancy
- Drug class: viral vaccines
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Further information
Afluria Preservative-Free Pediatric Quadrivalent side effects can vary depending on the individual. 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.