Vivaxim Adverse Reactions

Summary of the safety profile: During clinical studies, the most commonly reported reactions were those occurring at the injection site.
Pain at the VIVAXIM injection site was reported in 89.9% of subjects (severe in 4.5%). For subjects who received the two monovalent vaccines concomitantly at separate injection sites, pain was reported in 83.2% of subjects (severe in 5.0%) for both vaccine sites combined. Pain was reported by 79.3% of subjects (severe in 5.0%) at the Vi vaccine site and by 50.3% of subjects (severe in 0.6%) at the hepatitis A vaccine site.
Pain at the injection site lasting more than 3 days was reported by 17.4% of subjects after VIVAXIM, by 2.8% of subjects for the monovalent Vi vaccine site and by 0.6% of subjects for the monovalent hepatitis A vaccine site.
Severe oedema/induration (> 5 cm) was reported in 7.9% of subjects at the VIVAXIM injection site. For subjects who received the two monovalent vaccines concomitantly at separate injection sites, severe oedema/induration was reported in 1.7% of subjects for both vaccine sites combined (in 1.1% of subjects at the Vi vaccine site and in 0.6% of subjects at the hepatitis A vaccine site).
The overall incidence of systemic reactions was similar between subjects who were vaccinated with VIVAXIM and subjects who received the two monovalent vaccines concomitantly at separate injection sites.
All reactions resolved without any sequelae.
Tabulated list of adverse reactions: Adverse reaction data are derived from clinical trials and worldwide post-marketing experience.
Within each system organ class, the adverse reactions are ranked under headings of frequency, most frequent reactions first, using the following convention: Very common (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1000, <1/100), Rare (≥1/10,000, <1/1000), Very rare (<1/10,000), Not known: cannot be estimated from the available data. Based on spontaneous reporting, these adverse events have been very rarely reported during commercial use of VIVAXIM. Because events are reported spontaneously from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.
Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.
Immune system disorders: Not known: anaphylactic/anaphylactoid reactions, including shock; serum sickness.
Nervous system disorders: Very common: headache.
Uncommon: dizziness.
Not known: vasovagal syncope in response to injection, paraesthesia.
Gastrointestinal disorders: Common: nausea, diarrhoea.
Not known: vomiting, abdominal pain.
Skin and subcutaneous tissue disorders: Uncommon: pruritus, rash.
Not known: urticaria.
Musculoskeletal and connective tissue disorders: Very common: myalgia.
Common: arthralgia.
General disorders and administration site conditions: Very common: malaise, asthenia, injection site disorders (pain, induration, oedema, erythema).
Common: fever.
Investigations: Not known: transaminases increased (mild and reversible).
The following adverse reactions were not reported during the commercial use of VIVAXIM but were reported respectively following the use of the monovalent typhoid Vi polysaccharide vaccine and the monovalent inactivated hepatitis A vaccine.
Respiratory, thoracic and mediastinal disorders: Not known: aggravation of asthma.
General disorders and administration site conditions: Very rare: injection site nodule.
Paediatric Population: No data on the safety of VIVAXIM in children and adolescents below 16 years are available.