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サーバリックス後の抗SRP抗体陽性ミオパチーの症例

2016-11-10 | サーバリックス症例

 


 
VAERS ID: 524304 (history)   Vaccinated: 2011-12-03
Age: 12.0   Onset: 2011-12-03, Days after vaccination: 0
Gender: Female   Submitted: 2014-02-28, Days after onset: 818
Location: Foreign   Entered: 2014-02-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Biopsy muscle, Immune-mediated; Body temperature, 03Dec2011, 36.6C
CDC Split Type: B0971990A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX) GLAXOSMITHKLINE BIOLOGICALS AHPVA147AA 0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Biopsy muscle abnormal, Immune-mediated necrotising myopathy, Injected limb mobility decreased, Mobility decreased, Muscular weakness, Myositis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician via a regulatory authority (#V13001187) and described the occurrence of immune-mediated necrotizing myopathy in a 12-year-old female subject who was vaccinated with CERVARIX, (GlaxoSmithKline). On 3 December 2011, the subject received 1st dose of CERVARIX (intramuscular, administration site unknown). On 3 December 2011, in the afternoon, within hours of vaccination with CERVARIX, the subject experienced injected limb mobility decreased (difficulty to raise both upper limbs). On 7 January 2012, the subject received 2nd dose of CERVARIX (intramuscular, administration site unknown). In January 2012, less than one month after vaccination with CERVARIX, the subject experienced weakness of lower extremities. On 25 June 2012, the subject received 3rd dose of CERVARIX (intramuscular, administration site unknown). In July 2012, 1 month after vaccination with CERVARIX, the subject experienced arm weakness and abdominal muscle weakness. On an unspecified date, the subject developed symptom of reduction of running speed (decreased mobility). Immune-mediated necrotizing myopathy with anti-signal recognition particle antibody, which is a type of myositis, was diagnosed by muscle biopsy. On 6 September 2013, the subject was hospitalised and was discharged on 10 September 2013. At the time of reporting, immune-mediated necrotizing myopathy was unresolved. The outcome of the other events was unspecified.

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