Stamaril Adverse Reactions

Summary of the safety profile: Cases of serious adverse events such as severe hypersensitivity or anaphylactic reactions, neurotropic or viscerotropic disease (YEL-AND; YEL-AVD) have been reported from post-marketing experience (see Tabulated list of adverse reactions and Description of selected adverse reactions as follows).
In all clinical studies, 4896 subjects (all ages) received STAMARIL. In the most representative study in general population, the most frequently reported reactions (between 12% and 18% of subjects) were headache, asthenia, injection site pain and myalgia.
In the most representative study in toddler population, the most frequently reported reactions (between 32% and 35% of toddlers) were irritability, crying and appetite loss.
Adverse reactions usually occurred within the first three days following vaccination except pyrexia, which occurred between Day 4 and Day 14.
These reactions usually lasted for not more than 3 days.
Both local and systemic reactions were usually of mild intensity; however at least one severe injection site reaction was reported in 0.8% of subject in general population and in 0.3% of toddlers and at least one severe systemic reaction was reported in 1.4% of subjects in general population and 4.9% in toddlers.
Tabulated list of adverse reactions: The table as follows summarizes the frequencies of the adverse reactions that were recorded following vaccination with STAMARIL during clinical studies and worldwide post-marketing experience.
The adverse reactions 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).
Within each frequency grouping the adverse reactions are presented in the order of decreasing seriousness. (See table.)

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Description of selected adverse reactions: Cases of neurotropic disease (known as YEL-AND), some of which have had a fatal outcome, have been reported to occur within 30 days following vaccination with STAMARIL, and other yellow fever vaccines. YEL-AND may manifest as either encephalitis (with or without demyelination), or as a neurologic disease with peripheral nervous system involvement (e.g. Guillain-Barré syndrome). Encephalitis usually starts with high fever with headache that may progress to include encephalopathy (e.g. confusion, lethargy, personality change lasting more than 24 hours), focal neurologic deficits, cerebellar dysfunction or seizures. YEL-AND with peripheral nervous system involvement usually manifests as bilateral limb weakness or peripheral cranial nerve paresis with decreased or absent tendon reflexes (see Precautions).
Neurologic disease not meeting the criteria for YEL-AND has been reported. Manifestations may include cases of aseptic meningitis or seizure with no associated focal neurologic symptoms. Those cases are usually of mild or moderate severity and resolve spontaneously.
Cases of viscerotropic disease (known as YEL-AVD and formerly described as "Febrile Multiple Organ-System Failure") have been reported following vaccination with STAMARIL, and other yellow fever vaccines, some of which have been fatal. In the majority of cases reported, the onset of signs and symptoms was within 10 days after the vaccination.
Initial signs and symptoms are non-specific and may include pyrexia, myalgia, fatigue, headache and hypotension, potentially progressing quickly to liver dysfunction with jaundice, muscle cytolysis, thrombocytopenia and acute respiratory and renal failure (see Precautions).
Paediatric population: The safety of STAMARIL in paediatric population has been studied through a clinical study performed in 393 toddlers aged 12 to 13 months which received STAMARIL and placebo concomitantly.
The safety profile was assessed during the first 4 weeks following vaccination.
The following most frequently reported adverse reactions specific to the paediatric population were reported as "very common": irritability (34.7%), appetite loss (33.7%), crying (32.1%) and drowsiness (22%).
The other adverse reactions reported in toddlers were also reported from studies in general population: Injection site pain (17.6%), pyrexia (16.5%) and vomiting (17.1%) were reported as "very common" in toddlers. Pyrexia and vomiting were more frequently reported than in general population (see table as previously mentioned).
Injection site erythema (9.8%) and injection site swelling (4.4%) were reported as "common" in toddlers, like in general population, however with significantly higher frequencies compared to general population.
Other special population: Congenital or acquired immunodeficiency has been recognized as a potential risk factor for serious adverse events, including YEL-AND (see Contraindications and Precautions).
Age of more than 60 years (see Precautions) has been recognized as a potential risk factor for YEL-AVD and YEL-AND.
Age below 9 months (including infants exposed to vaccine through breastfeeding) (see Precautions) has been recognized as a potential risk factor for YEL-AND.
Medical history of thymus dysfunction or thymectomy (see Contraindications and Precautions) have been recognized as predisposing conditions for YEL-AVD.
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.