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Life Threatening? Yes
Write-up: Information has been received from Sanofi Pasteur MSD (E2014-03479) on 18-APR-2014. Case received from the Health Authorities on 16-Apr-2014 under the reference number MP20140253. A 15 year-old-female patient with no relevant medical history had received a first dose of GARDASIL (batch number not reported) via intramuscular route in March or April 2013. In May 2013, she developed headache, skin eruption, asthenia, arthralgia and myalgia which evolved. The patient received the second dose of GARDASIL (batch number not reported) via intramuscular route in July 2013. The causal link between the symptoms and vaccination was suggested since all the symptoms worsened following the second injection. The work-ups realised in December 2013 and February 2014 showed a normal brain MRI, normal thoraco-abdominal scan and a blood test with unremarkable biologic exploration. At the time of the report, the outcome was unknown. The Health Authorities assessed the causal relationship between the reported reactions and the vaccination as doubtful (C1 S2 I1) according to the method of assessment. It is noteworthy that the Health Authorities coded life-threatening and disability as seriousness criteria.
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