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Write-up: Information has been received from SPMSD (MFR. No. DK-1577272925-E2014-04827) on 02-JUN-2014. Case received from healthcare professional via Health Authorities on 28-May-2014 under the reference number DKMA-DK-ADR 22541136 and DK-DKMA-EFO8996. The primary reporter was a physician. The case is linked to case E2013-10742, same reporter had reported several case of POTS after GARDASIL vaccination. A 12 years old female patient (weight: 78 kg; height: 176 cm), had received the first dose of GARDASIL (batch number unknown) via intramuscular route of administration in not reported site of administration on unspecified date in 2008 and later on unspecified date in 2008 she developed chronic headache, dizziness, nausea, fainting, pronounced tiredness, abdominal pain, dyspnea, cognitive dysfunction, muscle spasm, tremor in muscles and on 01-Jan-2009 Postural Orthostatic Tachycardia Syndrome. The patient was previously healthy and physical active. After the first dose GARDASIL she suddenly developed chronic headache, dizziness, nausea, fainting, pronounced tiredness, abdominal pain, dyspnea, cognitive dysfunction, muscle spasm, tremor in muscles. The symptoms have gradually increased since 2008, but exact onset date cannot be reported as the symptoms has been going on for so many years. Syncope tendency is now declining. Tilt table test has been performed without syncope, but positive for POTS, despite high metoprolol dose. The HA reported onset of POTS as 01-Jan-2009. The symptoms have affected school attendance. The patient has been followed at a headache clinic at hospital due to the headache. The patient had received the second and third dose GARDASIL intramuscular on 09-Mar-2009 and 27-Mar-2009 respectively. Batch number is unknown. The reporter has used the following criteria for the diagnosis of POTS: 1. Heart rate increases greater than or equal to 30 bpm from supine to standing (10 min) in the absence of orthostatic hypotension (decrease in BP greater than 20/10 mmHg). 2. Symptoms worsen with standing and improved with recumbence. 3. Symptoms last greater than or equal to 6 months. 4. Absence of other overt cause of orthostatic symptoms or tachycardia (e.g., active bleeding, acute dehydration, medications). In addition, Hospital use an additional criteria in patients between 12-19 years: A heart rate increase greater than 40 bpm is required for the diagnosis, since young people have a stronger physiological heart rate response to standing. The use of the additional criteria is to avoid false positive diagnosis. At the time of reporting, the patient was recovering from fainting, but had not recovered from the rest of the events. The HA reported hospitalization and disability as seriousness criteria (no further info provided).
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