Verorab Adverse Reactions

Summary of the safety profile: Over 13,000 subjects, including approximately 1,000 children and adolescents under the age of 18, have received at least one dose of Verorab in clinical studies.
A combined analysis was performed on 3 randomised, controlled clinical studies with the same safety standards collecting data from 1001 subjects (17 infants/young children aged less than 24 months, 438 children and adolescents and 546 adults aged 18 to 60 years). In two studies, the vaccine was administered intramuscularly (n=402). In the third study (n=599), the subjects received the vaccine intradermally, and most of them received equine rabies immunoglobulins (ERIG) concomitantly with the first dose of Verorab.
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 effects, in all age groups (except in infants/young children aged under 24 months) were headache, malaise, myalgia and pain at the injection site. Injection site reactions (pain, erythema and swelling) were more common after an ID injection than an IM injection. Pain was the most common injection site reaction for both administration routes.
Tabulated list of adverse reactions: The adverse reactions listed as follows 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 5.)

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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.