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Life Threatening? No
Write-up: Information has been received via Sanofi Pasteur MSD (manufacturer control no. 2016000023) on 07-JAN-2016, as part of business agreement. Case received from physician via HA on 04-JAN-2016, under the reference number DKMA-WBS-0002113, DK-DKMA-WBS-0002176 and DK-DKMA-ADR 23278236. A 12-year-old female adolescent patient received GARDASIL, (batch number unknown, Dose 1) via intramuscular route on 10-NOV-2008, GARDASIL, (batch number unknown) via intramuscular route on 15-JAN-2009. The patient experienced Muscle pain on an unknown date, Asthma symptoms in NOV-2008, Anaphylactic shock on 15-JAN-2009, Dyspnoea on an unknown date, Postural orthostatic tachycardia syndrome on an unknown date, Dizziness on an unknown date, Cognitive dysfunction on an unknown date, menstrual pain aggravated on an unknown date, Food allergy on an unknown date, Fatigue extreme on an unknown date, Eczema on both arms in 2008, Sensory disturbance in fingers on an unknown date, Recurrent syncope on an unknown date, Frequent cystitis on an unknown date, Dry skin on an unknown date, Hyperventilation on an unknown date, Sleep disorder on an unknown date, Joint pain on an unknown date and Headache on an unknown date. The reporter has reported two times (ADR 23278236 is master case and ADR 23280817 is a duplicate). Therefore, DKMA has merged the two cases before being sent to agency. Agency can therefore consider version 2 and initial version. The patient was hospitalized on not reported date. Diagnostic criteria for POTS: 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). Symptoms worsen with standing and improved with recumbence. Symptoms last greater than or equal to 6 months. Absence of other overt cause of orthostatic symptoms or tachycardia (e.g., active bleeding, acute dehydration, medications) In addition, hospital uses an additional criterion for patients between 12-19 years old: need a pulse increase greater than 40bpm to confirm the diagnosis, based on that young people have a greater physiological pulse response upon standing up. This additional criterion is used to avoid false positives. The patient had a medical history of Dysmenorrhea. Additional investigations included Tilt Table Test fulfills diagnostic criteria for POTS n/a on an unknown date. At the time of reporting , the patient had recovered from anaphylactic shock (cessation date: not reported), was recovering from hyperventilation. The patient has not recovered from the other reactions.
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