Vaxigrip Adverse Reactions

Summary of the safety profile: The safety profile of Vaxigrip is based on data from 46 clinical studies in which approximately 17,900 participants from 6 months of age received Vaxigrip or Vaxigrip Tetra, and on the post-marketing surveillance.
Depending on immunization history and the age of the children, the number of doses was different (see Tabulated list of adverse reactions: Paediatric population as follows).
Most of adverse reactions usually occurred within the first 3 days after vaccination and resolved spontaneously within 1 to 3 days after onset. The intensity of most these reactions was mild to moderate.
The most frequently reported adverse reaction after vaccination, in all populations including the whole group of children from 6 to 35 months of age, was injection site pain.
In subpopulations of children less than 24 months of age and children from 24 to 35 months of age, the most frequently reported adverse reaction was irritability and malaise respectively.
Tabulated list of adverse reactions: The data as follows summarize the frequencies of the adverse reactions that were recorded following vaccination with Vaxigrip and/or Vaxigrip Tetra during clinical trials and worldwide post-marketing experience.
Adverse events are ranked under headings of frequency using the following convention: 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), Not known (cannot be estimated from available data): adverse reactions have been reported following commercial use of Vaxigrip or Vaxigrip Tetra based on spontaneous reporting. Because these reactions are reported voluntarily from populations of uncertain size, it is not possible to reliably estimate their frequency.
Adult and elderly: The safety profile is based on data: from clinical studies in more than 8,000 adults (5,064 for Vaxigrip, 3,040 for Vaxigrip Tetra) and more than 5,800 elderly over 60 years of age (4,468 for Vaxigrip, 1,392 for Vaxigrip Tetra), from worldwide post-marketing surveillance in the overall population (*). (See Table 10.)

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In adults, the most frequently reported adverse reactions after vaccination were injection site pain (52.8%), headache (27.8%), myalgia (23.0%), malaise (19.2%).
In the elderly, the most frequently reported adverse reactions after vaccination were injection site pain (25.8%), headache (15.6%), myalgia (13.9%).
Overall, adverse reactions were generally less frequent in the elderly than in adults and children.
Paediatric population: Depending on immunization history, children from 6 months to 8 years of age received one or two doses of Vaxigrip or Vaxigrip Tetra. Children/adolescents from 9 to 17 years of age received one dose.
In children from 6 months to 8 years of age, the safety profile was similar after the first and the second injections with a trend of lower incidence of adverse reactions after the second injection compared to the first one in children from 6 to 35 months.
Children/adolescents from 3 to 17 years of age: The safety profile is based on data: from clinical studies in 1,247 children from 3 to 8 years of age (363 for Vaxigrip, 884 for Vaxigrip Tetra) and in 725 children/adolescents from 9 to 17 years of age (296 for Vaxigrip, 429 for Vaxigrip Tetra), from worldwide post-marketing surveillance in the overall population (*). (See Table 11.)

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In children/adolescents from 9 to 17 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (65.3%), myalgia (29.1%), headache (28.6%), malaise (20.3%), shivering (13.0%), injection site erythema (11.7%) and injection site swelling (11.4%).
In children from 3 to 8 years of age, the most frequently reported adverse reactions after any vaccination were injection site pain (59.1%), malaise (30.7%), injection site erythema (30.3%), myalgia (28.5%), headache (25.7%), injection site swelling (22.1%), injection site induration (17.6%), and shivering (11.2%).
Children from 6 to 35 months of age: The safety profile is based on data: from one clinical study in 1,981 children from 6 to 35 months of age (367 for Vaxigrip, 1614 for Vaxigrip Tetra), from worldwide post-marketing surveillance in the overall population (*). (See Table 12.)

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In children from 6 to 35 months of age, the most frequently reported adverse reactions after any vaccination were injection site pain/tenderness (29.4%), fever (20.4%) and injection site erythema (17.2%).
In subpopulation of children from 6 to 23 months of age, the most frequently reported adverse reactions after any vaccination were irritability (34.9%), crying abnormal (31.9%), appetite lost (28.9%), drowsiness (19.2%) and vomiting (17.0%).
In subpopulation of children from 24 to 35 months of age, the most frequently reported adverse reactions after any vaccination was malaise (26.8%). myalgia (14.5%), headache (11.9%).
Other special populations: Although only a limited number of subjects with co-morbidities were enrolled, studies conducted in renal transplant patients or asthmatic patients, showed no major differences in terms of safety profile of Vaxigrip in these populations. The safety profile of Vaxigrip Tetra observed in a limited number of subjects with co-morbidities enrolled in the clinical studies does not differ from the one observed in the overall population.
Pregnant women: In clinical studies conducted in pregnant women in South Africa and Mali with Vaxigrip (see Use in Pregnancy & Lactation and Pharmacology: Pharmacodynamics under Actions), frequencies of local and systemic solicited reactions reported within 7 days following administration of the vaccine, were consistent with those reported for the adult population during clinical studies. In the study conducted in South Africa, local reactions were more frequent in the Vaxigrip group than in the placebo group in both HIV-negative and HIV-positive cohorts. There were no other significant differences in solicited reactions between Vaxigrip and placebo groups in both cohorts.
In one clinical study conducted in pregnant women in Finland with Vaxigrip and Vaxigrip Tetra (see Use in Pregnancy & Lactation and Pharmacology: Pharmacodynamics under Actions), frequencies of reported local and systemic solicited reactions were consistent with those reported for the non-pregnant adult population during clinical studies conducted with Vaxigrip or Vaxigrip Tetra even though higher for some adverse reactions (injection site pain, injection site erythema, malaise, shivering, headache, myalgia).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation 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.