- Body as a whole: Local injection site reactions (including pain, pain limiting limb movement, redness, swelling, warmth, ecchymosis, induration), hot flashes/flushes; chills; fever; malaise; shivering; fatigue; asthenia; facial edema.
- Immune system disorders: Hypersensitivity reactions (including throat and/or mouth edema). In rare cases, hypersensitivity reactions have lead to anaphylactic shock and death.
- Cardiovascular disorders: Vasculitis (in rare cases with transient renal involvement), syncope shortly after vaccination.
- Digestive disorders: Diarrhea; nausea; vomiting; abdominal pain.
- Blood and lymphatic disorders: Local lymphadenopathy; transient thrombocytopenia.
- Metabolic and nutritional disorders: Loss of appetite.
- Musculoskeletal: Arthralgia; myalgia; myasthenia.
- Nervous system disorders: Headache; dizziness; neuralgia; paraesthesia; confusion; febrile convulsions; Guillain-Barré Syndrome; myelitis (including encephalomyelitis and transverse myelitis); neuropathy (including neuritis); paralysis (including Bell’s Palsy).
- Respiratory disorders: Dyspnea; chest pain; cough; pharyngitis; rhinitis.
- Skin and appendages: Stevens-Johnson syndrome; sweating; pruritus; urticaria; rash (including non-specific, maculopapular, and vesiculobulbous).
The 1976 swine influenza vaccine was associated with an increased frequency of Guillain-Barré syndrome (GBS). Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly more than 1 additional case/1 million persons vaccinated.
Neurological disorders temporally associated with influenza vaccination such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy have been reported.
Microscopic polyangiitis (vasculitis) has been reported temporally associated with