Varilrix

Varilrix Adverse Reactions

vaccine, varicella-zoster

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Clinical trial data: Healthy subjects: More than 7,900 individuals have participated in clinical trials evaluating the reactogenicity profile of the vaccine administered alone or concomitantly with other vaccines.
The safety profile presented as follows is based on a total of 5,369 doses of Varilrix administered in monotherapy 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.
High-risk patients: There are only very limited data from clinical trials available in patients 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 surveillance: During post-marketing surveillance, the following additional reactions have been reported after varicella vaccination: See Table 3.

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