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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Case received from a Health Care Professional via the Health Authorities on 01-FEB-2012, under the reference numbers DK-DKMA-ADR 21460630, DK-DKMA-EF02041. Case medically confirmed. A 12 year old female patient had received an injection of GARDASIL, dose 2, batch number G004958, IM (dose not reported) on 13-DEC-2011 and later on, on an unspecified date, she developed global knee pain, swelling of left knee and redness. On 16-JAN-2012, approx. five weeks post vaccination, she experienced arthralgia. The patient presented with pain in left knee without known trauma or previous pathology. Clinical examination of global knee pain showed normal findings. Laboratory tests carried out on an unspecified date showed: normal values of differential count, serum C-reactive protein (CRP) and sedimentation rate (no values reported). The patient had previously received GARDASIL dose 1 at the same time as PRIORIX (dose, route and lot # not reported). On 11-OCT-2011, PRIORIX was reported as concomitant medication in the report. The patient was referred to the rheumatologist for further investigation. At the time of reporting, the outcome was unknown for swelling of left knee and redness and not yet recovered (also reported as unknown) for knee pain and arthralgia. The events were considered disabling by the agency. No causality assessments were provided. Other business partner numbers included: E2012-00650. No further information expected.
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