Priorix Adverse Reactions

In controlled clinical studies, signs and symptoms were actively monitored during a 42-day follow-up period. The vaccinees were also requested to report any clinical events during the study period.
The safety profile presented as follows is based on a total of approximately 12,000 subjects administered Priorix in clinical trials.
Frequencies are reported as: Very common (≥1/10)/ Common (≥1/100 to <1/10)/ Uncommon (≥1/1,000 to <1/100)/ Rare (≥1/10,000 to <1/1,000)/ Very rare (<1/10,000). (See Table 1.)

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In general, the frequency category for adverse reactions was similar for the first and second vaccine doses. The exception to this was pain at the injection site which was "Common" after the first vaccine dose and "Very common" after the second vaccine dose.
During post-marketing surveillance, the following reactions have been reported additionally in temporal association with Priorix vaccination: (See Table 2).

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Accidental intravascular administration may give rise to severe reactions or even shock. Immediate measures depend on the severity of the reaction (see Precautions).
In the comparative studies, a statistically significant lower incidence of local pain, redness and swelling was reported with Priorix compared with the comparator. The incidence of other adverse reactions listed previously was similar in both vaccines.