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Write-up: Information has been received from Sanofi Pasteur MSD (SPM) [Manufacturer Control Number DK-1577272925-E2014-08470] on 22-SEP-2014. Case received from a Health Care Professional via Health Authorities on 17-Sep-2014 under the reference number DK-DKMA-ADR 22690475. The primary reporter was a physician. A 14-year-old female patient (weight: 64 kg; height: 170 cm) with a medical history of mononucleosis, had second and third doses of GARDASIL (batch number not reported) via I.M. route of administration in unspecified site of administration on 23-Jan-2009 and 29-May-2009. Later in 25-Jan-2009 she developed autonomic dysfunction, neuropathic pain, arthralgia, fatigue extreme, headache, muscle pain, pain burning, orthostatic intolerance including syncope, abdominal pain, nausea, cognitive impairment, twitching, weakness of limbs and dyspnoea. On 15-Jan-2013 she developed syncope vasovagal, and on 25-Jan-2013 she developed allodynia (primarily in hands and feet). Further the patient developed menstruation irregular and poor quality sleep on unspecified date post vaccination. It was reported that the patient developed autonomic dysfunction, neuropathic pain, arthralgia, syncope vasovagal, fatigue extreme. Alongside the course of the adverse events she experienced symptoms such as headache, muscle pain and joint, burning pain and allodynia (primarily in hands and feet), orthostatic intolerance including syncope, abdominal pain, nausea, fatigue, cognitive impairment, twitching, weakness in limbs in arms and legs, dyspnoea, irregular menstruation, poor quality sleep. The symptoms first occurred closely after the second dose as regards time in 2008-2009 (somewhat contradictory to coded onset dates previously mentioned). A worsening of the adverse events was seen after a long-lasting mononucleosis-process in 2011-2012. During a tilt-table test in May 2014, a distinct increased pulse (65-$g123 bpm) was noticed, but the pulse stabilized on a lower level and does not fulfill the criteria for POTS. The patient experience asystole in 8 seconds during the tilt-table test. Other vaccines and other medicine when the adverse events occurred are unknown. The patient developed mononucleosis during the same period of time as the adverse events, however according to the Health Authority this is a part of her medical history. The patient have had mononucleosis during the period 2011-2012. The patient received first GARDASIL vaccination on 12-Dec-2008. At the time of reporting, the patient the outcome of syncope vasovagal was recovering, whereas other events were not yet recovered.
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