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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Information was obtained on a request by the company from the agency via a Public Case Details form concerning a 16 year old female who on 08-SEP-2008 was vaccinated with a dose of GARDASIL (batch number J2896, lot number 657872/0583U). On 08-SEP-2008, after second dose of GARDASIL the patient experienced generalized muscular weakness, severe headache-could not participate in sports at school. The next 5-6 weeks the patient experienced severe and continual headaches, muscle pain and weakness to the extent that the patient had to be carried to the toilet and was bed-bound. The mother also reported that student did not menstruate at all in between her first and second dose of GARDASIL. The mother also commented that the student had noticed "that she was sweating a lot" between dose 1 and dose 2 of GARDASIL. On 03-JUN-2009 the patient was still unwell and was experiencing the same symptoms, (severe headaches, muscle fatigue, has difficulty walking due to weakness) and extreme fatigue. The patient had not been able to return to school as too unwell. The patient was hospitalized for 1 week under the care of immunologist who diagnosed the patient with "post viral fatigue". The patient had been referred to a clinic for ongoing reaction with a physiologist and psychologist. At the time of reporting on 21-SEP-2009, the patient had not recovered. The agency considered that muscular weakness, amenorrhoea, fatigue, headache and hyperhidrosis were possibly related to therapy with GARDASIL. The original reporting source was not provided. No further information is available.
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