Adverse reactions were generally moderate in intensity and occurred within 3 days of vaccination. Most reactions resolved spontaneously within 1 to 3 days of their onset.
The most common adverse reactions, in all age groups (except infants/young children aged under 24 months) were headache, malaise, myalgia and pain at the injection site.
Tabulated list of adverse reactions: The adverse reactions listed below were reported during clinical studies and worldwide post-marketing surveillance. Within each system organ class, adverse reactions are ranked under headings of frequency using the following convention: Very common: ( ≥ 1/10); Common: (≥ 1/100 and < 1/10); Uncommon: ( ≥ 1/1,000 and < 1/100); Rare: (≥ 1/10,000 and < 1/1,000); Very rare: (< 1/10,000); Not known (cannot be estimated from the available data). (See Table 3.)
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Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
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