VaxigripTetra Side Effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Allergic reactions: See a doctor IMMEDIATELY if the adult or child experiences: Severe allergic reactions: that may lead to medical emergency with low blood pressure, rapid, shallow breathing, rapid heart rate and weak pulse, cold, clammy skin, dizziness, that may lead to collapse (shock). These side effects were not observed with VaxigripTetra but have been rarely reported with other vaccines given to prevent flu (may affect up to 1 in 1,000 people).
Swelling most apparent in the head and neck, including the face, lips, tongue, throat or any other part of the body and which may cause difficulty in swallowing or breathing (angioedema).
Allergic reactions such as skin reactions that may spread throughout the body including itching, hives, rash, redness.
These side effects are rare (may affect up to 1 in 1,000 people) except itching (pruritus) that may be more frequent (may affect up to 1 in 100 people).
Other side effects reported in adults and elderly: Very common (may affect more than 1 in 10 people): Headache, muscle pain (myalgia), malaise ⁽¹⁾, pain at the injection site.
⁽¹⁾ Common in elderly.
Common (may affect up to 1 in 10 people): Fever ⁽²⁾, shivering, reactions at the injection site: redness (erythema), swelling, hardness (induration).
⁽²⁾ Uncommon in elderly.
Uncommon (may affect up to 1 in 100 people): Dizziness ⁽³⁾, diarrhea, nausea ⁽⁴⁾, fatigue, reactions at the injection site: bruising (ecchymosis), itching (pruritus), and warmth.
⁽³⁾ Rare in adults. ⁽⁴⁾ Rare in elderly.
Hot flush: only seen in the elderly.
Swelling of the glands in the neck, armpit or groin (lymphadenopathy): only seen in adults.
Rare (may affect up to 1 in 1,000 people): Anomalies in the perception of touch, pain, heat and cold (paresthesia), sleepiness, increased sweating (hyperhidrosis), unusual tiredness and weakness (asthenia), flu-like illness.
Joint pain (arthralgia), discomfort at the injection site: only seen in adults.
Other side effects reported in children from 3 to 17 years of age: Very common (may affect more than 1 in 10 people): Headache, muscular pain (myalgia), malaise, shivering ⁽⁵⁾, reactions at the injection site: pain, swelling, redness (erythema) ⁽⁵⁾, hardness (induration) ⁽⁵⁾.
⁽⁵⁾Common in children from 9 to 17 years of age.
Common (may affect up to 1 in 10 people): Fever, bruising (ecchymosis) at the injection site.
Uncommon (may affect up to 1 in 100 people) in children from 3 to 8 years of age: Temporary reduction in the number of certain blood elements called platelets; a low number of these can result in excessive bruising or bleeding (transient thrombocytopenia): only seen in one child of 3 years of age.
Moaning, restlessness.
Dizziness, diarrhea, vomiting, upper abdominal pain, joint pain (arthralgia), fatigue, warmth at the injection site.
Uncommon (may affect up to 1 in 100 people) in children from 9 to 17 years of age: Diarrheoa, itching (pruritus) at the injection site.
Other side effects reported in children from 6 to 35 months of age: Very common (may affect more than 1 in 10 people): Vomiting ⁽¹⁾, muscular pain (myalgia) ⁽²⁾, irritability ⁽³⁾, appetite lost ⁽³⁾, generally feeling unwell (malaise) ⁽²⁾, fever.
⁽¹⁾ Uncommon in children from 24 to 35 months of age. ⁽²⁾ Rare in children less than 24 months of age.
⁽³⁾ Rare in children from 24 to 35 months of age.
Reactions at the injection site: pain/tenderness, redness (erythema).
Headache: only seen in children from 24 months of age.
Drowsiness, unusual crying: only seen in children less than 24 months of age.
Common (may affect up to 1 in 10 people): Shivering: only seen in children 24 months and older.
Reactions at the injection site: hardness (induration), swelling, bruising (ecchymosis).
Uncommon (may affect up to 1 in 100 people): Diarrhoea, hypersensitivity.
Rare (may affect up to 1 in 1,000 people): Flu-like illness, reactions at the injection site: rash, pruritus (itching).
In children from 6 months to 8 years of age who receive 2 doses, side effects were similar after the first and after the second dose. Fewer side effects may happen after the second dose in children from 6 to 35 months of age.
When seen, side effects generally happen in the first 3 days after the vaccination and go away by themselves in 1 to 3 days after they start. The intensity of observed side effects was mild.
Side effects were generally less frequent in elderly than in adults and children.
The following side effects have been reported after administration of Vaxigrip. These side effects may occur with VaxigripTetra: pain situated on the nerve route (neuralgia), convulsions, neurological disorders that may result in stiff neck, confusion, numbness, pain and weakness of the limbs, loss of balance, loss of reflexes, paralysis of part or all the body (encephalomyelitis, neuritis, Guillain-Barré syndrome); blood vessel inflammation (vasculitis) which may result in skin rashes and in very rare cases in temporary kidney problems.
Reporting of side effects: If the adult or child gets any side effects, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed in this monograph. By reporting side effects the patient can help provide more information on the safety of this medicine.