Verorab (Inactivated Purified Rabies Vaccine) Adverse Reactions

Undesirable effects were reported during clinical studies and after commercial use.
Undesirable effects are ranked in terms of frequency: very common: ≥ 1/10; common: ≥ 1/100 and < 1/10; uncommon: ≥ 1/1000 and < 1/100; rare: ≥ 1/10000 and < 1/1000; very rare: < 1/10000 including isolated cases.
Experience from clinical trials: Blood and lymphatic system disorders: Very common: Adenopathy/lymphadenopathy.
Immune system disorders: Common: Cutaneous allergic reactions such as rash, pruritus, oedema.
Uncommon: Urticaria, angiodema, dyspnoea.
Nervous system disorders: Common: Headache, dizziness, somnolence.
Gastrointestinal disorders: Common: Abdominal pain, nausea.
Uncommon: Diarrhoea.
Musculoskeletal and connective tissue disorders: Very common: Myalgia.
Common: Arthralgia, shivering.
General disorders and administration site conditions: Very common: Injection site pain (IM use), Injection site pain (ID use), Injection site erythema (ID use), fever, malaise.
Common: Injection site erythema (IM use), injection site pruritus (IM use), injection site pruritus (ID use), injection site swelling (IM use), injection site swelling (ID use), injection site haematoma (ID use), injection site induration (IM use), asthenia, influenza-like syndrome.
Experience after commercial use: In addition to the list as previously mentioned, the following undesirable effects were reported. Their exact incidence cannot be calculated as they were spontaneously reported. However, given the number of doses sold, the occurrence of these undesirable effects is very rare (<1/10000).
Immune system disorders: Anaphylactic reactions, serum sickness-like reactions.
Nervous system disorders: Encephalopathy, convulsions.
Ear and labyrinth disorders: Sudden hearing loss.*
*Which may persist.
Respiratory, thoracic and mediastinal disorders: Apnoea in very premature infants (born ≤ 28 weeks of gestation) (see PRECAUTIONS).
Gastrointestinal disorders: Vomiting.