Page 459 - TBE_Book_V2_2019

Chapter 14: Prevention

Table 3: Safety and Reactogenicity of FSME-IMMUN and Encepur (source: SMPCs)

Probability ≥1/10 ≥1/100 ≥1/1000 ≥1/10.000 Not known
<1/10 <1/100 <1/1000
FSME-Immun Local reaction Headache, Lymphadeno- Acute allergic Herpes Zoster (in pre-
at injection nausea, pathy, reactions, exposed individuals),
1st
vaccination: site: e.g., myalgia vomiting, fever somnolence, aggravation of
n=3512 Injection- site arthralgia, (only diarrhea, autoimmune disease,
pain malaise, exceptionally abdominal pain, anaphylactic reaction,
2nd fatigue. >39°C), vertigo, visual impairment,
vaccination: injection-site local reaction at photophobia, eye pain,
n=3477
hemorrhage. injection site: demyelinating
3rd redness, swelling, disorders,
vaccination: induration, pruritus, meningismus,
n=3277 paraesthesia, encephalitis, neuritis,
inflammation neuralgia, tachycardia,
tinnitus, dyspnea,
urticaria, rash,
pruritus, dermatitis,
erythema,
hyperhidrosis, back
pain, joint swelling,
neck pain,
musculoskeletal
stiffness, pain in
extremity, gait
disturbance, chills, flu-
like symptoms,
weakness, edema

Encepur Transient pain Redness, Arthralgia and Granuloma at Extremely rare:
at injection swelling at myalgia (neck), injection site,
(Pooled data Guillain-Barre
from clinical site, general injection vomiting diarrhea, arthralgia Syndrome
malaise, site, flu-like and myalgia in the
studies and
post- myalgia, symptoms, neck region,
headache fever ≥38°, lymphadenopathy,
marketing
nausea, neuritis-like
surveillance)
arthralgia symptoms, systemic
allergic reactions -
like urticaria,
dyspnea,
bronchospasm,
hypotension,
transient
thrombocytopenia

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