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. Agriflu (influenza virus vaccine, inactivated)." Novartis Pharmaceuticals, East Hanover, NJ.
4. "Product Information. Flucelvax 2015-2016 (influenza virus vaccine, inactivated)." Novartis Vaccines & Diagnostics Inc, Cambridge, MA.
5. "Product Information. Fluarix Quadrivalent 2015-2016 (influenza virus vaccine, inactivated)." GlaxoSmithKline, Research Triangle Park, NC.
6. "Product Information. Afluria 2015-2016 (influenza virus vaccine, inactivated)." bioCSL Inc, King of Prussia, PA.
7. "Product Information. Fluvirin 2015-2016 (influenza virus vaccine, inactivated)." Novartis Vaccines & Diagnostics Inc, Cambridge, MA.
8. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
9. Cerner Multum, Inc. "Australian Product Information." O 0
10. "Product Information. Fluzone Intradermal 2014-2015 (influenza virus vaccine, inactivated)." sanofi pasteur, Swiftwater, PA.
11. "Product Information. Fluzone Quadrivalent (influenza virus vaccine, inactivated)." Sanofi Pasteur, Toronto, IA.
12. "Product Information. Fluzone High-Dose 2015-2016 (influenza virus vaccine, inactivated)." sanofi pasteur, Swiftwater, PA.
13. "Product Information. Flublok 2015-2016 (influenza virus vaccine, inactivated)." Protein Sciences Corporation, Meriden, CT.
14. "Product Information. FluLaval 2014-2015 (influenza virus vaccine, inactivated)." GlaxoSmithKline, Research Triangle Park, NC.
15. "Product Information. Fluzone Influenza Vaccine (influenza virus vaccine)." Connaught, Swiftwater, PA.