Varilrix Adverse Reactions

Clinical trial data: Healthy subjects: More than 7,900 subjects have participated in clinical trials evaluating the reactogenicity profile of the vaccine administered subcutaneously either alone or concomitantly with other vaccines.
The safety profile presented as follows is based on a total of 5,369 doses of Varilrix administered alone to children, adolescents and adults.
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 2).

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A trend for higher incidence of pain, redness and swelling after the second dose was observed as compared to the first dose.
No difference was seen in the reactogenicity profile between initially seropositive and initially seronegative subjects.
In a clinical trial, 328 children aged 11 to 21 months received GSK's combined measles, mumps, rubella and varicella vaccine (containing the same varicella strain as Varilrix) either by subcutaneous or intramuscular route. A comparable safety profile was observed for both administration routes.
Individuals at high risk of severe varicella: There are only very limited data from clinical trials available in subjects at high risk of severe varicella. However, vaccine-associated reactions (principally papulo-vesicular eruptions and fever) are usually mild. As in healthy subjects, redness, swelling and pain at the site of injection are mild and transient.
Post-marketing data: The following additional adverse reactions have been identified in rare occasions during post-marketing surveillance. Because they are reported voluntarily from a population of unknown size, a true estimate of frequency cannot be provided: See Table 3.

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