Avaxim 80/Avaxim 160 Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Advise the patient to contact a doctor or healthcare professional immediately or go to the nearest hospital emergency department immediately if the patient experiences any allergic reactions that may be life-threatening. In general, these signs or symptoms appear very quickly after the injection and may include: difficulty breathing, blue colour of the tongue or lips, dizziness (low blood pressure) and possibly fainting, fast heart rate and weak pulse, cold skin, swelling of the face or neck, itching and skin rash.
Reporting of side effects: If the patient gets any side effects, advise the patient to talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed in this monograph.
By reporting side effects, it can help provide more information on the safety of this medicine.
Avaxim 80: Serious allergic reactions: Severe allergic reactions (anaphylactic reaction, including shock), although very rare, may occur after the vaccination.
Other side effects: Adverse reactions have been reported after the first dose (primary vaccination) and the second dose (booster dose) with the following frequencies: Very common adverse reactions (reported in more than 1 in 10 people): pain at the injection site⁽¹⁾, abnormal crying⁽¹⁾.
Common adverse reactions (reported by fewer than 1 in 10 people but more than 1 in 100): reduced appetite; irritability, insomnia; headache; stomach aches, diarrhoea, nausea, vomiting; muscle and joint pain⁽¹⁾; local reactions at the injection site such as pain⁽²⁾, redness, swelling or induration, bruising⁽¹⁾; malaise, fever, fatigue or drowsiness.
Uncommon adverse reactions (reported by fewer than 1 in 100 people but more than 1 in 1000): abnormal crying⁽²⁾, skin rash⁽²⁾, itching (hives)⁽¹⁾, joint pain⁽²⁾, haematoma at the injection site⁽²⁾.
Not known (the frequency cannot be estimated from the available data): fainting in response to injection, convulsions with or without fever.
⁽¹⁾ Frequency after first dose.
⁽²⁾ Frequency after second dose.
Overall, adverse reactions were reported less frequently after the second dose than after the first dose.
All adverse reactions were moderate and limited to the first few days after vaccination with spontaneous regression.
Avaxim 160: Serious allergic reactions: Serious allergic reactions, which can even be fatal (anaphylactic reaction, including shock), while very rare, can still occur after the vaccine.
Other adverse reactions: Very common reactions (reported by more than 1 in 10 people): mild injection site pain, fatigue.
Common reactions (reported by fewer than 1 in 10 people but by more than 1 in 100 people): headache; nausea, vomiting; loss of appetite; diarrhoea, abdominal pain; muscle and joint pain; mild fever.
Uncommon reactions (reported by fewer than 1 in 100 people but by more than 1 in 1,000 people): injection site redness.
Rare reactions (reported by fewer than 1 in 1,000 people but by more than 1 in 10,000 people): injection site bump, slight and transient modification of blood tests measuring liver activity.
Not known (cannot be estimated from the available data): fainting in response to injection, skin rash with or without itching.