Age: 14.0
Sex: F
Vaccine: HPV2
Symptoms: Temperature difference of extremities, Tremor
Clinical narrative: This case was reported by a physician via regulatory authority and described the occurrence of postural orthostatic tachycardia syndrome on a 15-year-old female patient who received CERVARIX (batch number AHPVA164AA, expiry date unknown). Previously administered products included CERVARIX (dose 1 - AHPVA162AA) and CERVARIX (dose 2 - AHPVA162AA). On 26th December 2012, the patient received the 3rd dose of CERVARIX. In December 2012, less than a month after receiving CERVARIX, the patient experienced postural orthostatic tachycardia syndrome (serious criteria hospitalization and disability), generalized aching and palpitation. On an unknown date, the outcome of the postural orthostatic tachycardia syndrome, generalized aching and palpitation were not recovered/not resolved. It was unknown if the reporter considered the postural orthostatic tachycardia syndrome, generalized aching and palpitation to be related to CERVARIX. Additional information: The case was reported by a physician (Neurology and rheumatology department) via the regulatory authority but it was confirmed the patient was vaccinated with all the 3 doses. The causal relationship to CERVARIX was unassessable. On 13 April 2015, after GSK internal review and requested clarification, it was confirmed the patient was not hospitalized and therefore hospitalization was removed as seriousness criteria. On 7 September 2015, this case has been identified as a duplicate of case JP2014JPN009776. Case JPN2014JPN009776 will be deleted and all future correspondence will be submitted to US2014GSK041878 which stands as the case of record. This case also reported in a literature article, this case corresponds to patient in the article: This case was reported in a literature article and it described a case of concurrent orthostatic dysregulation and complex regional pain syndrome I (according to the criteria of the Association) in a 15-year-old female subject who had received CERVARIX (GlaxoSmithKline). No information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, the subject received at least dose of CERVARIX (dosage, administration route and site unknown; batch number not provided). On an unknown date between 21 June 2013 and 31 March 2014, an unknown period after the administration of the vaccine, the subject presented with limb pain, limb tremors and decrease temperature in toe. The authors reported that some of the subjects had been severely disabled by their conditions. The subject underwent the following tests: Schellong test (maximum change decreased systolic blood pressure: 1 mmHg; increased heart rate/minute: 48), measurement of catecholamine plasma levels (Noradrenaline at supine position: 0.22 ng/mL, Increasing rate of noradrenaline: 100%), evaluation of skin temperature (2nd finger: 33.2, 1st toe: 24.1, room temperature 23-25 degC) and digital plethysmogram (2nd finger: decreased height of waves, 1st toe: decreased height of waves). In addition to this, a punch biopsy of the skin of the first toe was performed and no pathological findings were identified. Upon light microscopic examination, three small nerve fascicles were identified in one skin sample and some of these nerve fascicles were near apocrine glands (where sudomotor autonomic unmyelinated nerves were thought to be present, according to the authors). Upon electron microscopic examinations, one fascicle was found to consist of a small number of myelinated nerve fibers (most of them less than 5 um in diameter) and a large number of unmyelinated nerve fibers. Treatment was unknown. At the time of reporting the outcome of the events was unspecified. The authors mentioned that a causal relationship between the human papillomavirus vaccine and the events described in the article could be possible. They argued that this possibility was reinforced by the unusual concurrence of complex regional pain syndrome and orthostatic dysregulation in some of the subjects, as well as the lack of preceding viral infections in the 4 subjects diagnosed with postural orthostatic tachycardia syndrome. The authors concluded that "The symptoms observed in this study can be explained by abnormal peripheral sympathetic responses. The most common previous diagnosis in the studied girls was psychosomatic disease. The social problems of the study participants remained unresolved in that the severely disabled girls stopped going to school". This case is 1 of the 22 valid cases reported in the same literature article.