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Write-up: Information has been received from a physician via SPMSD (Sender''s case report number DK-1577272925-E2014-08762) on 29-SEP-2014. Case received from Health Care Professional via Health Authorities on 24-Sep-2014 under the reference number DK-DKMA-ADR 22697427 and DK-DKMA-EFO9953. The primary reporter was a physician. A female patient (weight: 43 kg; height: 167 cm) with no reported medical history, had received three injections of GARDASIL (batch numbers not reported) via I.M. route of administration in unspecified site of administration on 24-Nov-2010, 26-Jan-2011 and 29-Jun-2011, and later she developed postural orthostatic tachycardia syndrome (POTS) and orthostatic hypotension in December 2011, syncope vasovagal in October 2012 and orthostatic intolerance, headache, delayed menstruation (late 2-3 months), stomach pain, concentration impaired and muscle twitching on an unknown date. Side Effects: Postural orthostatic tachycardia syndrome (POTS), orthostatic hypotension and syncope vasovagal. The reporter noted that it was somewhat uncertain with the temporal relationship as the family had a hard time remembering exactly when the symptoms started compared to the GARDASIL vaccine, but the family suspected a causal relationship. The patient had now symptom complex of syncope, severe orthostatic intolerance, headache, delayed menstruation (started when she was 12 years old, but last menstruation is late - so far two to three months), abdominal pain, difficulty concentrating, muscle "twitch". By tilt table test in September 2013 found Postural Orthostatic Tachycardia Syndrome (POTS). By tilt table test in September 2014, the orthostatic tachycardia in decline - but orthostatic hypotension growing - the patient had almost immeasurably low blood pressure when standing, and the syncopes were increasing. 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 understanding 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 the additional criteria is to avoid false positive diagnosis. It was unknown whether the patient had other vaccines or medicines. The patient had no reported relevant medical history. The patient is somewhat underweight. In September 2013 POTS was found by tilt table test. The diagnosis was reconfirmed with tilt table test in September 2014. The orthostatic tachycardia was decreasing but orthostatic hypotension was increasing. The patient had very low pressure standing. At the time of reporting, the patient had not recovered, but the outcome of POTS was reported as recovering. This case has been linked to master case E2013-10742, as the patient was diagnosed with POTS at syncope center at hospital by the physician post vaccination.
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