Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Affect lability, Cognitive disorder, Computerised tomogram head normal, Dyskinesia, Encephalitis
Clinical narrative: Initial and follow up information has been received from a physician via the Agency (agency # V14000583) concerning a 14 year old girl. Information has been received for a direct report from the Agency regarding a case provided by the physician. No information on underlying/concurrent disease was provided. The patient had no past medical history of brain tumor, stroke, Alzheimer's disease, abuse of alcohol or illegal drugs, head trauma or injury, central nervous system (CNS) infection, diabetes mellitus/hyperglycaemia/hypoglycaemia, electrolyte imbalance and others as well as seizure, convulsion and epilepsy. There were no instructions on family in particular, and the patient had no special notes on the pre-vaccination interview form (including underlying disease, allergy, status of growth, weeks of pregnancy in case of during pregnancy, vaccination/medical history during recent one month, medications currently taken, past history of adverse drug reaction). On 27-SEP-2011, at 16:18, the patient received the first vaccination with GARDASIL (dose not reported, lot# 1336Z, batch #9QN01R, expiration date 03-NOV-2013) intramuscular at hospital A. The body temperature before the vaccination was 36.5 degrees Celsius. Special notes on the pre-vaccination interview form: None. On 02-DEC-2011, at 18:01, the patient received the second vaccination with GARDASIL (dose not reported, batch no. 9QN02R, lot# 0108AA, expiration date 26-JAN-2014) intramuscular at hospital A. The body temperature before the vaccination was 36.5 degrees Celsius. Special notes on the pre-vaccination interview form: None. On 31-MAR-2012, at 11:21, the patient received the third vaccination with GARDASIL intramuscular injection drug (dose not reported, batch no. 9QN03R, lot no.0277AA) at hospital A. The body temperature before vaccination was 36.5 degrees Celsius. Special notes on the pre-vaccination interview form: None. Other concomitant medications were not reported. On an unspecified date (after the vaccination), the patient visited hospital A for receiving influenza vaccine and medical care for cold. No apparent neurological abnormalities were noted. The patient did not seem to complain of any stress or pain and appeared just as a normal high school student. On 07-SEP-2012, the patient became aware of weakness in the right upper and lower extremities (onset of convulsion) when she was watching television in the living room. Symptoms of convulsion included mild weakness of the right lower extremity, convulsion of the right upper arm, and involuntary movements and these symptoms lasted 60 minutes. The patient presented to hospital B, where head CT (computerized tomography) scan showed no abnormalities. The patient walked on crutches when going to school. On 08-SEP-2012, the patient visited hospital C, where she had a general examination. No abnormalities were noted and a diagnosis of stress was given. On 17-SEP-2012 (10 days after the development of convulsion), weakness of the left lower extremity was noted. The patient was unable to stay in upright position or walk. In her home, she crawled to move forward and used a wheelchair to go to school. On an unspecified date, the patient was referred to and visited hospital D to receive counseling, but no improvement was noted. On an unspecified date, during the night, the patient shed tears laughing and saying that she did not want to laugh but could not help laughing, and wanted her mother to stop it. Hyperpnoea was also noted. The patient was emergently transferred to medical center E, but the cause was unknown. In late November 2012, the weakness of both legs improved and the patient was able to stand. She began walking training. In around April 2013, as the symptoms were improved, the patient returned to usual lifestyle pattern and spent time without incident for a while. On 28-AUG-2014, involuntary movements of the right upper extremity occurred. The patient visited hospital F with a complaint that her right arm involuntarily moved and she could not work on her summer holiday homework. Blood test and CT scan were performed with the suspect of convulsion due to heat illness, but it showed no abnormalities. On 29-AUG-2014, involuntary movements on the right upper arm persisted, and the patient visited the neurological department of hospital G, where she was referred to hospital H. On an unspecified date (approximately 3 days after the onset of the right upper extremity symptom), the symptom of the right upper extremity was resolving. From 01-OCT-2014 to 05-OCt-2014, the patient had weakness of the right upper extremity. On 06-OCT-2014, the patient presented to hospital A. At the visit, although weakness on the right lower extremity was slightly improving, the patient complained that convulsion and involuntary movements on the right upper arm since August still occasionally occurred. Convulsion and apparent involuntary movements of the right upper arm was noted at the visit. At the time of this report on 19-NOV-2014, convulsion was resolving. At the time of the report on 17-FEB-2015, all the events had not resolved. [Questionnaire on convulsion] Prodromal symptoms of seizure/convulsion/epilepsy: Medical history of seizure/convulsion/epilepsy: None, Onset time of recent seizure/convulsion: 07-SEP-2012, Frequency of episodes: one episode of seizure/convulsion per annum, Onset date of seizure/convulsion immediately before the event: Not provided, Recent monitoring for blood concentrations of an antiepileptic drug in case that the patient was on the therapy: Not applicable; Information of the patient immediately before the onset of the event (seizure/convulsion): Use of concomitant drugs including over-the-counter drug (OTC), crude drug, nutritional supplement within 1 month after the onset of the event: None, Recent dose change of concomitant medications: Not provided, Risk factors inducing seizures: Recent alcohol drinking: No, Lack of sleep: No, Exposure to flash light (stroboscope, TV, video games) or unpleasant sound: No, Recent massive coffee consumption: No, Recent use of vitality-enhancing drugs: No, Other risk factors: None; Situation when the event occurred: watching TV in the living room; Diagnosis and classification of seizure/convulsion: All signs/symptoms of the event: mild weakness of the right lower extremity, convulsion of the right upper arm, and involuntary movements (documented by an observer), Onset date of the event: 07-SEP-2012; duration : 60 min, Therapy duration until the onset of the event: Not provided, Classification of seizures based on the International League Against Epilepsy ([LAE) classification (1981): partial seizures (simple partial seizures without disturbances in consciousness), Tests/diagnostic data: Not provided. <Survey for symptoms developed after vaccination for human papillomavirus infection> Name of vaccine: GARDASIL, Date of vaccination: 1st dose on 27-SEP-2011, 2nd dose on 02-DEC-2011, 3rd dose on 31-MAR-2012, The date the patient's condition was last checked: 24-JAN-2015, The date the form was completed by the reporter: 05-FEB-2015, The patient's current condition with respect to the symptoms developed after vaccination: Not recovered, Currently ongoing symptoms among those developed after vaccination: Non-vaccination site pain (excluding arthralgia, myalgia and headache), Convulsion, Muscular weakness, Involuntary movement, Movement disorder (excluding convulsion, muscular weakness and involuntary movement), Orthostatic dysregulation, Decreased cognitive function (including dyscalculia/memory impairment), Malaise (including long-term fatigue), Other (specifically): Affective incontinence and difficulty in walking, Treatment provided in response to each symptom developed after vaccination: Symptom: Non-vaccination site pain (excluding arthralgia, myalgia and headache), convulsion, muscular weakness, involuntary movement, movement disorder (excluding convulsion, muscular weakness and involuntary movement), orthostatic dysregulation, decreased cognitive function (including dyscalculia/memory impairment), malaise (including long-term fatigue), affective incontinence and difficulty in walking -Treatment type: No treatment/Observation - Treatment outcome: Ineffective, Hospitalization required due to symptoms developed after vaccination: -No, Assistance required for daily living activities due to symptoms developed after vaccination: -Yes (duration: SEP-2012 - 24 JAN-2015) ongoing, Continuing influence on going to school or work due to symptoms developed after vaccination: -Yes; there had been a period when the patient sometimes could not go to school or work (duration: SEP-2012 - 26-JAN-2015) ongoing. Comment from a physician of hospital A: Before the vaccination, the patient had no problem with her health condition in particular. No problem was found in the examination before the vaccination as well. The vaccination was performed on the left deltoid with the usual procedure. Since the neurological abnormality seen at the examination on 06-OCT-2014 was apparent, the physician felt that the vaccination should not be resumed until the causal relationship between the symptoms and vaccination became clear. Comment from the reporting physician of hospital I: Sudden involuntary movement was characteristic of this case. The symptoms has not improved. Involuntary movement was predominant symptom and the symptom was considered unlikely or less likely to resolve. The reporting physician of hospital A considered the convulsion as serious due to threat of disability. The reporting physician felt that the causality as serious due to threat of disability. The reporting physician of hospital A felt that the causality of convulsion to GARDASIL was unknown with no other possible causative factors (other diseases). The reporting physician of hospital A did not assess the seriousness of difficulty in walking and movement disorder (excluding convulsion, muscular weakness and involuntary movement). The reporting physician of hospital I felt that convulsion , atonic seizures, pain, muscular weakness, involuntary movement, difficulty in standing, memory impairment, malaise, affective incontinence, myokymia, encephalitis, encephalopathy and perceptual disturbance were related to GARDASIL and did not assess other possible causative factors including other diseases. The reporting physician of hospital A did not assess the causal relationship of difficulty in walking and movement disorder (excluding convulsion, muscular weakness and involuntary movement) to GARDASIL. Additionally, information has been received for a direct report form the Agency regarding a case provided by the physician pertaining to this case. Additional information has been requested. Patient age, narrative, AEs, the causal relationship were updated.