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Found 251 cases where Vaccine is HPV or HPV2 or HPV4 and Symptom is Mental disability or Mental disorder or Mental disorder due to a general medical condition or Mental impairment or Mental retardation or Mental retardation severity unspecified or Mental status changes

Case Details

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VAERS ID: 620363 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-07-19
Onset:0000-00-00
Submitted: 2015-12-28
Entered: 2015-12-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA123BA / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abnormal dreams, Apathy, Atonic seizures, Autonomic nervous system imbalance, Back pain, Blood catecholamines decreased, Blood test normal, Constipation, Cytogenetic analysis normal, Decreased appetite, Disturbance in attention, Dizziness postural, Dyscalculia, Dyskinesia, Dysmenorrhoea, Electroencephalogram normal, Gait disturbance, Headache, Hyperacusis, Initial insomnia, Listless, Loss of personal independence in daily activities, Malaise, Menstruation irregular, Mental impairment, Middle insomnia, Mobility decreased, Motion sickness, Muscle tightness, Muscle twitching, Muscular weakness, Musculoskeletal stiffness, Neuropathy peripheral, Neuropsychological test, Nuclear magnetic resonance imaging brain normal, Photophobia, Photosensitivity reaction, Post vaccination syndrome, Premenstrual dysphoric disorder, Restless legs syndrome, Restlessness, Sensory disturbance, Sleep disorder, Thyroid function test normal, Tremor, Trismus, Walking aid user, Weight bearing difficulty, Weight decreased, Wheelchair user
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Akathisia (broad), Dyskinesia (narrow), Dystonia (narrow), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Fertility disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Epilepsy
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN179677

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of atonic seizures in a female subject who received CERVARIX (batch number AHPVA123BA, expiry date unknown) and (batch number AHPVA149BA, expiry date unknown). The subject''s past medical history included epilepsy. On 15th June 2011, the subject received the 1st dose of CERVARIX (intramuscular). On 19th July 2011, the 2nd dose was an unknown dose. On 2nd February 2012, the 3rd dose was an unknown dose. In July 2011, unknown after receiving CERVARIX, the subject experienced mental concentration decreased and listless. In August 2011, the subject experienced restless legs syndrome. In September 2011, the subject experienced atonic seizures (serious criteria hospitalization) and tremor finger (serious criteria hospitalization). In April 2015, the subject experienced premenstrual dysphoric disorder. In May 2015, the subject experienced appetite absent, weight decreased and difficulty in walking. On an unknown date, the subject experienced musculoskeletal stiffness (serious criteria hospitalization), cerebration impaired (serious criteria GSK medically significant), headache, low back pain, menstruation irregular, menses painful, photophobia, hyperacusis, dizziness on standing up, car sickness, constipation chronic, sleep disorder, dyscalculia, rigidity masticatory, tightness of back muscles, twitching facial, shaking, mobility decreased, malaise, lower extremities weakness of, restlessness, weight bearing difficulty, hands weakness of and post vaccination syndrome. The subject was treated with TEGRETOL, LUVOX, and. On an unknown date, the outcome of the atonic seizures, tremor finger, musculoskeletal stiffness, cerebration impaired, mental concentration decreased, listless, restless legs syndrome, premenstrual dysphoric disorder, appetite absent, weight decreased, difficulty in walking, headache, low back pain, menstruation irregular, menses painful, photophobia, hyperacusis, dizziness on standing up, car sickness, constipation chronic, sleep disorder, dyscalculia, rigidity masticatory, tightness of back muscles, twitching facial, shaking, mobility decreased, malaise, lower extremities weakness of, restlessness, weight bearing difficulty, hands weakness of and post vaccination syndrome were unknown. It was not reported if the reporter considered the atonic seizures, tremor finger, musculoskeletal stiffness, cerebration impaired, mental concentration decreased, listless, restless legs syndrome, premenstrual dysphoric disorder, appetite absent, weight decreased, difficulty in walking, headache, low back pain, menstruation irregular, menses painful, photophobia, hyperacusis, dizziness on standing up, car sickness, constipation chronic, sleep disorder, dyscalculia, rigidity masticatory, tightness of back muscles, twitching facial, shaking, mobility decreased, malaise, lower extremities weakness of, restlessness, weight bearing difficulty, hands weakness of and post vaccination syndrome to be related to CERVARIX. In July 2011, during the summer break just after the second CERVARIX vaccination, the subject lost concentration and motivation, and "her mind became strange", and she became unable to sit for a long time. Around August 2011, she had strange feeling in the palms and soles, and had an impulse to scrabble (restless legs syndrome). In September 2011, the subject had atonic seizures, and experienced tremor of hands and feet involuntary (tremor finger). Her legs were rather rigid. She was transported to Hospital A by an ambulance. Head magnetic resonance imaging (MRI) and electroencephalogram were conducted at the hospital, but no abnormality was detected. Her consciousness remained clear throughout that time. She was hospitalized for about 10 days. Although a blood test was conducted, it revealed no abnormality. She was told that her symptoms may be psychogenic. The subject visited several clinics, and underwent psychological tests. However, a cause could not be identified. Although CERCINE and AKINETON were prescribed, the symptoms did not improve. The subject additionally visited University Hospital B, and Neurological Clinic C. However, no abnormality was noted from gene analyses and examinations related to Segawa''s disease. From the viewpoint of neurology, the muscle stiffness of lower limbs was similar to dystonia, but was considered as not so indeed. Blood tests revealed a lower dopamine level in the body, and TANADOPA and TEGRETOL were prescribed. In 2012, when the subject was in the third year of high school, she was frequently absent from school. However, she graduated from the high school, and passed an entrance exam to a university. At the entrance exam, as she was unable to fill out mark sheets due to tremor finger-like movement involuntary, she sat on the exam as a special admission student. In April 2015, the pre-existing lowering of mood before menstruation had progressed, and oral LUVOX was added. Around May 2015, weakness of limbs and tremor-like movement involuntary gradually worsened, and inappetence also progressed, which led to weight loss. The subject started using a taxi to school due to difficulty in walking, and required a stick when commuting to school. She was a dedicated student with excellent academic grades. On 09 July 2015, the subject visited the reporting pediatric department for the first time. She was in the second year of the university. She did not have generalized aching, but squeezing-like headache persisted after developing on awakening. No paroxysmal headache was noted. She had intense low back pain. Her menstruation was more irregular then before, and recently, the amount of menstruation flow varied from large to small, which involved black-colored blood clot-like substances. She also had intense period pains. Basal body temperature had been altered, and high-temperature period was not noted (anovular menorrhagia). Regarding photosensitivity, intense movement involuntary developed over the whole body upon light stimulation at electroencephalogram. Sound sensitivity was also noted. Dizziness on standing up and car sickness were both intense. Although she had intense chronic constipation, constipation and diarrhoea did not repeat alternatively. The patterns of movement involuntary started varying in many ways. She had tremor-like and dystonia-like symptoms, muscle stiffness, neck swaying, and a head forward posture with her back bent forward. However, movement involuntary disappeared while she was sleeping. Movement involuntary became intense with accumulated fatigue load. Sleep disorder also progressed, and recently, she frequently had trouble falling asleep, saw a lot of dreams, and also had nocturnal awakening. Calculation disturbance was also noted, and she required more time to do a simple subtraction than before. She found it difficult to continue reading books, as she could not comprehend the contents and often stopped reading in the middle of books (during the worst of the symptoms, she could not even recognize the fact that she was reading books). She sometimes used a wheelchair at school, and required help from her friends when moving around school. The subject complained of difficulty in speaking as her tongue became rigid, inability to maintain her back straight (she was unable to control the back muscles), inability to eat as she had a strange sensation with her tongue, muscle twitching of the face (including eyes and cheeks), her neck swaying sideways, persistent voluntary movements of limbs, malaise, lack of strength in her knees (her knees suddenly knocked), restlessness, inability to take meals smoothly as she could not lift herself up properly, and inability to pick up a book due to weakness of hands. Physical findings: Muscle pain on grasping in the upper-limb muscle: (+). Arthritis: Negative. Tender points: (+). Blood tests: Inflammatory findings: None. Thyroid functions: Normal. Screening of collagen disorder: No abnormality. Progression of the pathological condition was noted from pain disorder including headache, headache dull, and low back pain, to strange sensation of limbs (restless legs syndrome), to abnormal menstruation (anovular menorrhagia), to tremor-like involuntary movements including difficulty in walking, stiff legs and tremor fingers, to sleep disorder, to autonomic nervous system disorders including dizziness on standing up, car sickness and chronic constipation, to sensory disturbance including photosensitivity and sound sensitivity, and to higher brain dysfunction including mental concentration decreased, calculation disturbance and comprehension insufficiency of book contents. As these symptoms worsened with factors such as atmospheric depression (typhoon) and mental stress, typical human papillomavirus vaccination associated with neuropathic syndrome (HANS) was diagnosed.


VAERS ID: 620366 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-03-01
Onset:0000-00-00
Submitted: 2015-12-28
Entered: 2015-12-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA1644AA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Autonomic nervous system imbalance, Back pain, Cognitive disorder, Cystitis, Dizziness postural, Dyskinesia, Dysmenorrhoea, Haematuria, Headache, Hyperhidrosis, Hypoaesthesia, Menstrual disorder, Menstruation irregular, Mental impairment, Mobility decreased, Motion sickness, Muscle tightness, Muscular weakness, Myalgia, Myofascial pain syndrome, Neuropathy peripheral, Pain in extremity, Pollakiuria, Post vaccination syndrome, Seizure, Sensory disturbance, Tinnitus, Tremor, Urinary retention, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hearing impairment (narrow), Vestibular disorders (narrow), Fertility disorders (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Tubulointerstitial diseases (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN179690

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of cerebration impaired in a female subject who received CERVARIX (batch number AHPVA162BA, expiry date unknown) and (batch number AHPVA164AA, expiry date unknown). On 31st August 2011, the subject received the 1st dose of CERVARIX (intramuscular). On 21st October 2011, the 2nd dose was an unknown dose. On 1st March 2012, the 3rd dose was an unknown dose. On 26th December 2013, 2 years and 118 days after receiving CERVARIX, the subject experienced convulsion (serious criteria GSK medically significant), body numbness and movements involuntary. On 1st December 2014, the subject experienced abdominal pain. On an unknown date, the subject experienced cerebration impaired (serious criteria GSK medically significant), feeling of residual urine (serious criteria GSK medically significant), post vaccination syndrome, low back pain, myofascial low back pain, muscular weakness, pain of lower extremities, menses painful, headache, irregular menstrual cycle, menstrual disorder, dizziness on standing up, car sickness, sweaty hands, cognitive disorder, tremor limb, vertigo, tinnitus, cystitis, haematuria, pollakiuria, knee pain, muscle tightness, tenderness muscle, autonomic dysfunction and sensory disturbance. The subject was treated with memantine. On an unknown date, the outcome of the cerebration impaired, convulsion, feeling of residual urine, post vaccination syndrome, low back pain, myofascial low back pain, body numbness, movements involuntary, muscular weakness, pain of lower extremities, menses painful, headache, irregular menstrual cycle, menstrual disorder, dizziness on standing up, car sickness, sweaty hands, cognitive disorder, tremor limb, vertigo, tinnitus, cystitis, abdominal pain, haematuria, pollakiuria, knee pain, muscle tightness, tenderness muscle, autonomic dysfunction and sensory disturbance were unknown. It was not reported if the reporter considered the cerebration impaired, convulsion, feeling of residual urine, post vaccination syndrome, low back pain, myofascial low back pain, body numbness, movements involuntary, muscular weakness, pain of lower extremities, menses painful, headache, irregular menstrual cycle, menstrual disorder, dizziness on standing up, car sickness, sweaty hands, cognitive disorder, tremor limb, vertigo, tinnitus, cystitis, abdominal pain, haematuria, pollakiuria, knee pain, muscle tightness, tenderness muscle, autonomic dysfunction and sensory disturbance to be related to CERVARIX. Low back pain developed after the first and the second vaccinations. The subject visited the plastic surgery department B, where myofascial low back pain was diagnosed. On 26 December 2013, after arriving home from school, she experienced numbness of the left leg, and convulsion (involuntary movement). She visited the plastic surgery department B. Muscle weakness was also noted, and she underwent magnetic resonance imaging (MRI), which revealed no abnormality. Pain-relief drug and compress were prescribed. The numbness of the left leg and pain persisted thereafter, and she occasionally became unable to move at school. She made regular visits to Orthopedic Hospital C for rehabilitation and electrical therapy. In November 2014, the above mentioned symptoms started occurring every day. On 27 November 2014, she visited the reporting department for the first time with chief complaints of pain from the lower back to the legs, numbness and convulsion. Intense period pains, which she had never had before, developed with headache at the same time. Menstrual irregularity developed, and menstrual flow became mucous and blackish. Dizziness on standing up, which she had never experienced before, and car sickness had been worsening. Sweaty hands were noted. No sleep disorder was noted. Her mental concentration was assumed to be retained, but memory ability had been decreasing, and she was suffering from forgetfulness. She was able to walk normally, and was able to write characters. Subsequently, she started suffering from intense headache, and tremor-like shaking of hands and feet was observed. She became unable to move due to giddiness and tinnitus. On 03 December 2014, abdominal pain worsened, and she visited Hospital D with chief complaints of pollakiuria and feeling of residual urine. Cystitis was diagnosed, based on positive urinary occult blood and positive urinary protein. Medications including memantine were started, with which headache and shaking improved but gonalgia worsened. Status of school attendance: She attended school through pain by using supporter. Physical education: She participated in classes, as attendance was given only when she participated in the face of pain. Results of relevant tests and procedures associated with the diagnosis: Physical examinations: Fibromyalgia (FM) tender points: All positive. Muscle pain on grasping: Strong with abnormal muscle tightness. Pathological reflux: Negative. Blood tests: Inflammatory findings: (-). Thyroid function: Normal. Screening of collagen disorder: No abnormality. Multi-layering of the symptoms was noted from pain disorders (low back pain, headache, and pain in extremity), to numbness, to involuntary movement, to decreased loco-motor function including muscle weakness, to abnormal menstruation, to autonomic dysfunction, to sensory disturbance (tinnitus), and to higher brain dysfunction, for which typical human papillomavirus vaccination associated with neuropathic syndrome (HANS) was diagnosed.


VAERS ID: 620369 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-08-01
Onset:2011-08-01
   Days after vaccination:0
Submitted: 2015-12-28
   Days after onset:1610
Entered: 2015-12-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA149BA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Antinuclear antibody, Antinuclear antibody negative, Arthralgia, Asthenia, Atonic seizures, Autonomic nervous system imbalance, Blood test normal, Carbon dioxide decreased, Cataplexy, Chest pain, Cognitive disorder, Constipation, Diarrhoea, Disturbance in attention, Dizziness postural, Double stranded DNA antibody, Dyspnoea, Dysstasia, Fall, Fatigue, Headache, Immediate post-injection reaction, Inflammatory marker test, Initial insomnia, Liver function test normal, Loss of personal independence in daily activities, Malaise, Mental impairment, Nausea, Neuropathy peripheral, Palpitations, Post vaccination syndrome, Renal function test normal, Sleep disorder, Thyroid function test normal, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Seasonal allergy; Rhinitis allergic
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN179687

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of cataplexy in a female subject who received CERVARIX (batch number AHPVA138BA, expiry date unknown), (batch number AHPVA145AA, expiry date unknown) and (batch number AHPVA149BA, expiry date unknown). Concurrent medical conditions included pollinosis and rhinitis allergic. On 1st August 2011, the subject received the 1st dose of CERVARIX (intramuscular). On 2nd September 2011, the 2nd dose was an unknown dose. On 3rd February 2012, the 3rd dose was an unknown dose. On 1st August 2011, immediately after receiving CERVARIX the subject experienced headache. On an unknown date, the subject experienced cataplexy (serious criteria GSK medically significant), cerebration impaired (serious criteria GSK medically significant), astasia, malaise, dizziness on standing up, car sickness, chest pain, diarrhoea, constipation, palpitations, shortness of breath, vomiting, weakness, loss of posture, concentration loss, cognitive deterioration, feeling queasy, trouble falling asleep, arthralgia, autonomic dysfunction and post vaccination syndrome. On an unknown date, the outcome of the cataplexy, cerebration impaired, headache, astasia, malaise, dizziness on standing, up car sickness, chest pain, diarrhoea, constipation, palpitations, shortness of breath, vomiting, weakness, loss of posture, concentration loss, cognitive deterioration, feeling queasy, trouble falling asleep, arthralgia, autonomic dysfunction and post vaccination syndrome were unknown. It was not reported if the reporter considered the cataplexy, cerebration impaired, headache, astasia, malaise, dizziness on standing, up car sickness, chest pain, diarrhoea, constipation, palpitations, shortness of breath, vomiting, weakness, loss of posture, concentration loss, cognitive deterioration, feeling queasy, trouble falling asleep, arthralgia, autonomic dysfunction and post vaccination syndrome to be related to CERVARIX. Before the vaccination, the subject had never experienced diseases that required hospitalization. She was absent from school 1-2 times a year. She participated in volleyball and table tennis in elementary and junior high school respectively. Her academic performance was above average. On 01 August 2011, after the first vaccination, headache developed (she had never complained of headache before). In 2011, after the second HPV vaccination, headache developed more frequently. She could not wake up in the morning due to headache, and became late for school or absent from school more frequently (she could not wake up until afternoon when she was absent). In October 2011, she visited the internal medicine department. In November 2011, she visited the psychiatry department. In January 2012, she visited the headache outsubject department and the psychiatry department. In 2012, she visited the internal medicine department occasionally. After March 2012, she was late for school 27 times in 6 months, and was absent from school for 24 days in total. Headache and malaise were intense, and dizziness on standing up, car sickness, and chest pain developed additionally. She became more susceptible to diarrhoea and constipation. No generalized aching was noted. She had palpitations, shortness of breath and headache by just placing her leg on stairs. Sometimes, she had repeatedly experienced vomiting every time she walked. She also had experienced fall due to weakness (cataplexy). No abnormal menstruation had been noted so far. Mental concentration had been decreased. She was able to write characters. When she read books, the contents slipped out of her head, as if the line of sight was slipping over the letters. On 14 August 2014, she visited the reporting department for the first time. The intensity of tiredness and malaise, headache, and queasy feeling peaked at that time. Sleep disorder (trouble falling asleep) progressed, and repeating constipation and diarrhoea worsened. The prescriptions she had received so far at the medical institutions included headache medications, antidepressants and vasopressors. At the time of reporting, she visited the department of psychosomatic medicine. No prescription was made. Status of school attendance: From September 2011 to March 2012: Absence, 24 days: tardy, 27 times In the first year of high school: Absence, 23 days; tardy 39 times In the second year of high school: Absence, 24 days; tardy, 77 times In the third year of high school, the number of absence and tardy remained large. Even when she attended school, she often attended to the school dispensary. She was unable to participate in physical education classes. Blood tests: Inflammation, collagen disorder, thyroid function, liver function, and renal function: No abnormality Anti-nuclear antibody was 40-fold, but the nuclear form was homogeneous pattern. A series of autoantibodies (anti-double strand DNA antibody, anti-ribonucleoprotein (RNP) antibody, and anti-Ro (SS-A) antibody) were negative. Although generalized aching was absent, multi-layering of the symptoms from pain disorder including headache, arthralgia and chest pain, to abnormal tiredness and malaise, to sleep disorder, to atonic seizures and cataplexy, to autonomic dysfunction including dizziness on standing up, palpitations and repeating constipation and diarrhoea, and to higher brain dysfunction including decreased mental concentration and insufficient comprehension of contents of books developed immediately after the HPV vaccination, which led to a diagnosis of human papillomavirus vaccination associated with neuropathic syndrome (HANS).


VAERS ID: 620370 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-10-24
Onset:0000-00-00
Submitted: 2015-12-28
Entered: 2015-12-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA149AA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Arthralgia, Arthritis, Aspiration joint, Blood test, Dermatitis acneiform, Dysmenorrhoea, Immediate post-injection reaction, Initial insomnia, Joint effusion, Joint swelling, Learning disorder, Malaise, Menstruation irregular, Mental impairment, Middle insomnia, Mood swings, Neuropathy peripheral, Pain, Post vaccination syndrome, Rash erythematous, Sleep disorder, Somnolence, X-ray
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Fertility disorders (broad), Hypersensitivity (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN179678

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of cerebration impaired in a 17-year-old female subject who received CERVARIX (batch number AHPVA148CB, expiry date unknown), (batch number AHPVA149AA, expiry date unknown) and (batch number AHPVA161BA, expiry date unknown). On 27th September 2011, the subject received the 1st dose of CERVARIX (intramuscular). On 24th October 2011, the 2nd dose was an unknown dose. On 30th March 2012, the 3rd dose was an unknown dose. On an unknown date, unknown after receiving CERVARIX, the subject experienced cerebration impaired (serious criteria GSK medically significant), arthralgia, rash acneiform, generalised aching, malaise, trouble falling asleep, nocturnal awakening, somnolence, irregular menstrual cycle, menses painful, knee swelling, arthritis, learning disorder, mood variable, feeling anxious and post vaccination syndrome. The subject was treated with CELECOX, Predonine and methotrexate. On an unknown date, the outcome of the cerebration impaired, generalised aching, malaise, nocturnal awakening, somnolence, knee swelling and post vaccination syndrome were unknown and the outcome of the arthralgia, rash acneiform and arthritis were recovering/resolving and the outcome of the trouble falling asleep, irregular menstrual cycle, menses painful, learning disorder, mood variable and feeling anxious were not recovered/not resolved. It was not reported if the reporter considered the cerebration impaired, arthralgia, rash acneiform, generalised aching, malaise, trouble falling asleep, nocturnal awakening, somnolence, irregular menstrual cycle, menses painful, knee swelling, arthritis, learning disorder, mood variable, feeling anxious and post vaccination syndrome to be related to CERVARIX. Immediately after the second vaccination with CERVARIX, arthralgia developed. The arthralgia only involved the joints of both hand at the beginning, but it was gradually spread to the joints of ankle, neck, and shoulders. The patient had a hard time in the bathroom and crouching down because of the arthralgia, and even sometimes could not sleep due to the intense pain. Deep red colored rash acneform developed on the face. The patient occasionally visited an orthopedic department for joint fluid aspiration and used an analgesic. However, the patient still had intense arthralgia on hands in the morning, which eventually eased off slightly in the evening. After the third vaccination with CERVARIX, the arthralgia worsened and generalised aching was noted. On 06 March 2014, the patient visited an orthopedic clinic for the first time. After an X-ray examination and blood tests were performed, fluid was removed from the knees. On 12 June 2014, the patient visited the reporting department for the first time. The chief complaint was generalised aching, arthralgia and malaise. The headache was not significant, but the patient had a light sleep with trouble falling asleep and nocturnal awakening, and sometimes fell asleep in a day time unexpectedly. In addition, the patient sometimes fell to her knees due to weakness. No photosensitivity or hyperacusis was noted. After receiving vaccination with CERVARIX, menstrual irregularity developed with menstrual bleeding twice in a month. The blood was often dark red and included much mucus-like fluid. Menses painful became worsened. Physical examination revealed deep red colored rash acneform on the face. Joint swelling was noted on both knees. Ultrasound joint tests revealed bursal fluid accumulation and outgrowths of synovial membrane. In addition, an evidence of treatment given on the elbow joints and lateral malleolus of ankles was noted. Matrix metalloproteinase (MMP)-3 was slightly increased to 63.9. The arthritis was considered as the similar clinical condition as rheumatoid arthritis. On 11 September 2014, therapy with Predonine (prednisolone) 10 mg/day and methotrexate 10 mg/week was initiated. Improvement in generalised aching, arthritis findings and rash acneform was noted. However, sleep disorder (trouble falling asleep) as well as menstrual irregularity with intense menses painful still persisted. In addition, the patient could not come up with Chines character. As great mood swings and irritability occurred, sometimes the patient ended up with abusive language. The disease condition markedly progressed. Blood test findings: No evidence of inflammation, normal thyroid function, Collagen disorder screening results of 40-fold antinuclear antibody and individual autoantibody tests with negative results. The differential diagnosis for this case included juvenile idiopathic arthritis (polyarticular, seronegative, poly-JLA). Given the patient had poly-JLA, it may explain the arthritis on multiple sites, malaise and mood swings, while it does not generally cause rash acneform, sleep disorder, menstrual irregularity or higher brain dysfunction. Furthermore, the patient had joint fluid accumulation on the multiple joints despite the slightly low MMP-3 level of 63.9. Patients with untreated poly-JLA typically have MMP-3 levels beyond 100ng/ml. Based on the above consideration, this case was diagnosed as human papillomavirus vaccination associated with neuropathic syndrome, which mainly involved arthritis after HPV vaccination and developed from rash to sleep disorder to menstrual irregularity to higher brain dysfunction.


VAERS ID: 620371 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-11-14
Onset:0000-00-00
Submitted: 2015-12-28
Entered: 2015-12-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA149AA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Apathy, Arthralgia, Autonomic nervous system imbalance, Back pain, Chest pain, Cognitive disorder, Disturbance in attention, Dizziness, Dizziness postural, Ear pain, Exercise tolerance decreased, Eye pain, Gait disturbance, Gastrointestinal motility disorder, Glare, Headache, Hyperhidrosis, Hypersomnia, Hypoaesthesia, Listless, Loss of personal independence in daily activities, Malaise, Memory impairment, Menstrual disorder, Menstruation irregular, Mental impairment, Motion sickness, Myalgia, Neuropathy peripheral, Pain, Pain in extremity, Photophobia, Post vaccination syndrome, Sensory disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Gastrointestinal obstruction (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Ocular motility disorders (broad), Fertility disorders (broad), Arthritis (broad), Noninfectious diarrhoea (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN179685

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of cerebration impaired in a 12-year-old female subject who received CERVARIX (batch number AHPVA123BA, expiry date unknown) and (batch number AHPVA149AA, expiry date unknown). On 7th May 2011, the subject received the 1st dose of CERVARIX (intramuscular). On 18th June 2011, the 2nd dose was an unknown dose. On 14th November 2011, the 3rd dose was an unknown dose. On an unknown date, unknown after receiving CERVARIX, the subject experienced cerebration impaired (serious criteria GSK medically significant), post vaccination syndrome, gonalgia, pain in elbow, generalised joint pain, pain, pain of lower extremities, myalgia, difficulty in walking, malaise, headache, low back pain, glare, dizziness on standing up, dizziness, motion sickness, sweaty hands, alternation between constipation and diarrhoea, abdominal pain, exercise tolerance decreased, irregular menstrual cycle, menstrual disorder, forgetfulness, mental concentration decreased, lack of motivation, cognitive disorder, numbness of limbs, sleep excessive, eye pain, ear pain, tenderness muscle, chest pain, sensory aberrations and autonomic dysfunction. On an unknown date, the outcome of the cerebration impaired, post vaccination syndrome, gonalgia, pain in elbow, generalised joint pain, pain, pain of lower extremities, myalgia, difficulty in walking, malaise, headache, low back pain, glare, dizziness on standing up, dizziness, motion sickness, sweaty hands, alternation between constipation and diarrhoea, abdominal pain, exercise tolerance decreased, irregular menstrual cycle, menstrual disorder, forgetfulness, mental concentration decreased, lack of motivation, cognitive disorder, numbness of limbs, sleep excessive, eye pain, ear pain, tenderness muscle, chest pain, sensory aberrations and autonomic dysfunction were unknown. It was not reported if the reporter considered the cerebration impaired, post vaccination syndrome, gonalgia, pain in elbow, generalised joint pain, pain, pain of lower extremities, myalgia, difficulty in walking, malaise, headache, low back pain, glare, dizziness on standing up, dizziness, motion sickness, sweaty hands, alternation between constipation and diarrhoea, abdominal pain, exercise tolerance decreased, irregular menstrual cycle, menstrual disorder, forgetfulness, mental concentration decreased, lack of motivation, cognitive disorder, numbness of limbs, sleep excessive, eye pain, ear pain, tenderness muscle, chest pain, sensory aberrations and autonomic dysfunction to be related to CERVARIX. On unknown date, after the first vaccination, the subject had gonalgia and arthralgia in elbows, which were persistent. The subject was given 3 doses of the vaccine in her first year of middle school. The subject became a high school student. The arthralgia had expanded to the whole body and was not limited to the joint sites, but to the periarticular sites. The soles of the feet also became painful. The subject attended school in the face of the pain. From autumn to winter in 2014 (at the first year of high school), the generalized arthralgia and myalgia got worse, which resulted in walking difficulty. The subject was more frequently absent from the school. The subject visited Orthopedic Clinic B. An X-ray showed no abnormality and the subject was only prescribed analgetics, and had not visited the clinic afterward. The listlessness/malaise was persisting. The subject had headache persisting from morning, which was a problem in her life. The subject also had severe low back pain. On 29 October 2015, the subject visited the reporting department for the first time. The subject felt dazzling of lights (sunlight or fluorescent lights). Auditory hyperacuity was not noted. The lightheadedness, giddiness and car sickness (motion sickness in a train) got worse. The subject had sweaty hands. The subject had no palpitations. The subject experienced constipation and diarrhoea repeatedly, with occasional abdominal pain. Her physical strength was decreasing. The subject used to have regular menstruation, but recently it became irregular and she often had menstruation twice a month. The menstrual blood was black, and occasionally associated with blood clots. The subject often experienced forgetfulness. The subject had mental concentration decreased and avolition. She could not understand the written examination questions in the national language class and she took more time to read books. She lost her place in the book while reading the book. The subject had numbness in extremities, but no involuntary movements were noted. The subject had no sleep disorder, and had rather excessive sleep. She sometimes found herself sleeping in the classroom. Her eyes and ears became painful. Results of relevant tests and procedures associated with the diagnosis: Physical examinations: Fibromyalgia (FM) tender points: Positive for all the sites (18/18 sites). Muscle pain on grasping in the brachial / thigh muscles. Strong tension in the trapezius muscle. Chest/ abdominal pain. Blood tests: Inflammatory findings: Negative, Thyroid functions: Negative, Screening for collagen disorder: Anti-nuclear antibodies, 1:160 (homogeneous/speckled); anti-double stranded DNA antibodies, negative: anti-SS-A antibodies, negative; and anti-ribonucleoprotein (RNP) antibodies, negative. Rheumatoid factor (RF): Negative. Matrix metalloproteinase-3 (MMP-3): Negative (24.4). Status of Attending School: The subject attended classes at the high school, while having hard time because of generalized arthralgia and myalgia. The subject could not perform physical activities. In this case, the subject''s symptoms progressed to painful disorder, followed by listlessness/malaise, followed by menstruation abnormal, followed by sensory aberrations, followed by autonomic dysfunction and then higher cerebral dysfunction, and were becoming increasingly multi-layered over time. Accordingly, human papillomavirus (HPV) vaccination associated with neuropathic syndrome was diagnosed.


VAERS ID: 620372 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-06-30
Onset:0000-00-00
Submitted: 2015-12-28
Entered: 2015-12-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA161BA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Anxiety, Apathy, Autonomic nervous system imbalance, Blood test normal, Cognitive disorder, Decreased appetite, Diarrhoea, Disturbance in attention, Dizziness postural, Dysmenorrhoea, Fatigue, Feeling abnormal, Glare, Headache, Hypersomnia, Hypoaesthesia, Irritability, Loss of personal independence in daily activities, Malaise, Menstrual disorder, Menstruation irregular, Mental impairment, Nausea, Neuropathy peripheral, Nuclear magnetic resonance imaging brain abnormal, Orthostatic intolerance, Parosmia, Photophobia, Post vaccination syndrome, Somnolence, Thyroid function test normal
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Ocular motility disorders (broad), Fertility disorders (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Arteriovenous malformation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN179684

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of cerebration impaired in a female subject who received CERVARIX (batch number AHPVA148AA, expiry date unknown), (batch number AHPVA149AA, expiry date unknown) and (batch number AHPVA161BA, expiry date unknown). Concurrent medical conditions included arteriovenous malformation. On 22nd October 2011, the subject received the 1st dose of CERVARIX (intramuscular). On 19th November 2011, the 2nd dose was an unknown dose. On 30th June 2012, the 3rd dose was an unknown dose. On an unknown date, unknown after receiving CERVARIX, the subject experienced cerebration impaired (serious criteria GSK medically significant), post vaccination syndrome, headache, feeling queasy, malaise, hard to awaken, mental concentration decreased, feeling anxious, dizziness on standing up, floating feeling, orthostatic dysregulation, diarrhoea, abdominal pain, irregular menstrual cycle, menses painful, menstrual disorder, headache dull, sleep excessive, glare, altered smell sensation, numbness of limbs, cognitive disorder, lack of motivation and autonomic dysfunction. On an unknown date, the outcome of the cerebration impaired, post vaccination syndrome, headache, feeling queasy, malaise, hard to awaken, mental concentration decreased, feeling anxious, dizziness on standing up, floating feeling, orthostatic dysregulation, diarrhoea, abdominal pain, irregular menstrual cycle, menses painful, menstrual disorder, headache dull, sleep excessive, glare, altered smell sensation, numbness of limbs, cognitive disorder, lack of motivation and autonomic dysfunction were unknown. It was not reported if the reporter considered the cerebration impaired, post vaccination syndrome, headache, feeling queasy, malaise, hard to awaken, mental concentration decreased, feeling anxious, dizziness on standing up, floating feeling, orthostatic dysregulation, diarrhoea, abdominal pain, irregular menstrual cycle, menses painful, menstrual disorder, headache dull, sleep excessive, glare, altered smell sensation, numbness of limbs, cognitive disorder, lack of motivation and autonomic dysfunction to be related to CERVARIX. After the vaccination in June 2012, headache developed frequently. When the headache was intense, it was associated with queasy feeling. The number of early-leave became noticeable. Abnormal tiredness and malaise gradually worsened, and the subject grew irritable with decreased mental concentration. Dizziness on standing up occurred every time, and she constantly had a floating feeling of the body. She visited Clinic B, where she was told that the symptoms were something specific to puberty. Around spring in 2013, she visited the adolescent outpatient department of Hospital C on referral from Clinic B. Orthostatic dysregulation was diagnosed, and she started receiving counseling. In addition, cerebral arteriovenous malformation was noted in magnetic resonance imaging (MRI). From July 2013 to August 2013, she visited the department of neurosurgery of Hospital D, where cerebral arteriovenous malformation was diagnosed. In April 2014, coil embolization was conducted at Hospital D (without craniotomy). After the end of treatment, she regularly visited the hospital. No change was noted with the headache thereafter. In addition, she was suffering from abdominal pain with diarrhoea, menstrual irregularity (with occasional amenorrhoea for 1-2 months), and intense period pains. In September 2015, in addition to headache (with headache dull, without queasy feeling), tiredness and malaise were intense and she felt like lead and became unable to wake up. She could finally wake up after 15:00 or after 19:00 at worst. She could eat dinner, but continued not taking breakfast or lunch. A series of symptoms persisted every day, but the intensity peaked especially before periods. She found light too bright, and hyperosmia was noted. The length of sleep prolonged extraordinarily. Although she could sleep for all time, she did not have much trouble falling asleep or nocturnal awakening. Numbness of limbs was present, while shaking of hands and feet was absent. She did not make many mistakes with simple calculations, but became unable to recall and write certain characters. She could not understand the contents of books when reading, and lost motivation for reading. On the other hand, she was able to recall recent memories. She lacked motivation in life overall. Status of school attendance: She had hardly been able to attend school since she was in the third year of junior high school. She attended a correspondence high school. Although she attended some days, she suffered from intense malaise on the next day, which made her absent from school for 3-4 days. From the second semester onwards, she had not been able to attend school at all. Results of relevant tests and procedures associated with the diagnosis: Physical examinations: Fibromyalgia (FM) tender points: (-), Muscle pain on grasping: (-), Inflammatory findings: (-), Chest and abdomen: No findings. Blood tests: Inflammation: None, Thyroid function: No abnormality, Screening of collagen disorder: No abnormality. Human papillomavirus vaccination associated with neuropathic syndrome (HANS) was diagnosed in this case, based on the following facts: Extensive physical signs including headache, tiredness and malaise, sleep disorder (excessive sleep), numbness of limbs, abnormal menstruation, autonomic dysfunction and higher brain dysfunction (mild) were observed; multi-layering of the symptoms was observed; and no abnormality was noted in examinations including blood tests. Besides, this subject underwent coil embolization for the cerebral arteriovenous malformation that was detected during close examination of headache. However, the focus itself cannot serve as an explanation for such complicated clinical symptoms.


VAERS ID: 620373 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-28
Entered: 2015-12-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA123BA / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Acupuncture, Amnesia, Arthralgia, Asthenia, Atonic seizures, Autonomic nervous system imbalance, Bedridden, Blindness transient, Blood test normal, Cognitive disorder, Computerised tomogram head normal, Decreased appetite, Dehydration, Depressed level of consciousness, Discomfort, Disturbance in attention, Dizziness, Dizziness postural, Dyscalculia, Dysmenorrhoea, Dysstasia, Electrocardiogram normal, Emotional distress, Fall, Fatigue, Headache, Hyperacusis, Hyperventilation, Irritability, Loss of consciousness, Loss of personal independence in daily activities, Malaise, Memory impairment, Mental impairment, Muscle tightness, Neuropathy peripheral, Orthostatic intolerance, Palpitations, Photophobia, Photosensitivity reaction, Post vaccination syndrome, Seizure, Sleep disorder, Tension, Tremor, Vomiting, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Arthritis (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN179696

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of consciousness decreased in a female subject who received CERVARIX (batch number AHPVA123BA, expiry date unknown), (batch number AHPVA143CA, expiry date unknown) and (batch number AHPVA156BA, expiry date unknown). On 20th July 2011, the subject received the 1st dose of CERVARIX (intramuscular). On 26th August 2011, the 2nd dose was an unknown dose. On 8th March 2012, the 3rd dose was an unknown dose. In 2011, unknown after receiving CERVARIX, the subject experienced consciousness decreased (serious criteria GSK medically significant) and lightheadedness. On 8th July 2013, the subject experienced loss of consciousness (serious criteria hospitalization and GSK medically significant) and convulsion (serious criteria hospitalization and GSK medically significant). In June 2014, the subject experienced weight decreased. On 28th June 2014, the subject experienced discomfort. On an unknown date, the subject experienced blackout spell (serious criteria GSK medically significant), transient visual loss (serious criteria GSK medically significant), cerebration impaired (serious criteria GSK medically significant), autonomic dysfunction, atonic seizures, headache, malaise, hyperpnoea, tremor limb, vomiting, difficulty in standing, dizziness on standing up, orthostatic dysregulation, bedridden, global amnesia, sleep disorder, concentration ability impaired, dyscalculia, cognitive function abnormal, memory impairment, photophobia, hyperacusis, tense, appetite impaired, arthralgia, muscle tightness, post vaccination syndrome and palpitations. The subject was treated with METLIGINE. On an unknown date, the outcome of the consciousness decreased, blackout spell, loss of consciousness, convulsion, transient visual loss, cerebration impaired, lightheadedness, autonomic dysfunction, atonic seizures, headache, malaise, hyperpnoea, vomiting, difficulty in standing, dizziness on standing up, orthostatic dysregulation, bedridden, global amnesia, sleep disorder, concentration ability impaired, dyscalculia, cognitive function abnormal, memory impairment, photophobia, hyperacusis, tense, appetite impaired, weight decreased, discomfort, arthralgia, muscle tightness, post vaccination syndrome and palpitations were unknown and the outcome of the tremor limb was recovered/resolved. It was not reported if the reporter considered the consciousness decreased, blackout spell, loss of consciousness, convulsion, transient visual loss, cerebration impaired, lightheadedness, autonomic dysfunction, atonic seizures, headache, malaise, hyperpnoea, tremor limb, vomiting, difficulty in standing, dizziness on standing up, orthostatic dysregulation, bedridden, global amnesia, sleep disorder, concentration ability impaired, dyscalculia, cognitive function abnormal, memory impairment, photophobia, hyperacusis, tense, appetite impaired, weight decreased, discomfort, arthralgia, muscle tightness, post vaccination syndrome and palpitations to be related to CERVARIX. Before the vaccination, the subject had had normal school life. Tardy and early leave were rare. Her academic performance was above the average. After the first CERVARIX vaccination, symptoms including losing her consciousness and lightheadedness developed. The subject thought that she had anaemia and observed it while trying to take iron-containing meals. A local physician pointed out dysautonomia. Atonic seizures developed occasionally. She was suffering from intense headache in the morning and terrible tiredness. She experienced hyperpnoea during the practice of a brass band club at junior high school. She also experienced shaking of hands and feet during ab exercises at the club, which improved with rehydration after she arrived home. Painful menses was intense, for which she had been transported to a hospital by an ambulance before. When she was in the third year of junior high school, she blacked out while walking, and also had experienced fall on the platform. She often vomited in a restroom and collapsed on the floor in a train as she could not keep standing due to weakness. When commuting to high school, she often experienced dizziness on standing up at the platform and was put in a sitting position with her arms being supported by people around her. On 28 April 2013, the subject visited the outpatient service for giddiness at the otolaryngology department, where orthostatic dysregulation was diagnosed. METLIGINE was prescribed. From 08 May 2013, she became unable to wake up in the morning due to headache and tiredness. Even when she had conversation with her mother at the time of awakening, it was often noted that she did not remember any of it at all. Sleep disorder was noted. She stayed in bed all day long from time to time. On 12 June 2013, the subject visited a specialty outpatient clinic for orthostatic dysregulation. The physician told the symptoms were psychological. Vasopressor and Chinese herbal medicines were prescribed. On 08 July 2013, at noon, she lost her consciousness and had convulsion at home, for which she was transported to Hospital A by ambulance. She was treated with intravenous drip infusion for suspected dehydration, and she was once sent home in the late afternoon. However, she was re-transported to the hospital as convulsion recurred. She was admitted to the hospital for a day. Examinations including imaging of head and electrocardiogram were conducted, but no abnormal finding was noted. She also underwent acupuncture and moxa cautery 2-3 times a week. On 28 June 2014, the subject visited the reporting department for the first time with chief complaints of losing consciousness, feelings of weakness, tiredness and malaise, headache, period pains, mental concentration decreased, inability to do simple calculations, inability to understand the contents of books, and memory impairment. Photosensitivity and sound sensitivity were noted. Hyperosmia was not noted. Hallucination and auditory hallucination were not noted. She could not control her emotions, and often got irritated. Appetite impaired was noted (her height was 163-165 cm and the weight was 40 kg, which was previously 45-47 kg). She felt sick during the medical examination, and lied down on a bed. Subsequently at the outpatient department, general malaise was intense, and she complained of migratory arthralgia. The symptoms that were observed at the first visit were persisting. School attendance: She became unable to attend high school from 08 May 2014, and attendance disorder had been persisting. In September, she was transferred to a correspondence high school. On 08 July 2013: Imaging of head and electrocardiogram revealed no abnormal findings. On an unknown date: Physical findings: Fibromyalgia (FM) tender points: (-), Muscle tension: Positive, Muscle pain on grasping: Negative. Findings of blood tests: Inflammatory findings: None, Screening of collagen disorder: Negative. A progression of the symptoms was noted after the vaccination, from pain disorder including headache and arthralgia, to tiredness and malaise, to abnormal menstruation, to sensory disturbance including photosensitivity and sound sensitivity, and to higher brain dysfunction including decreased mental concentration, inability to do calculations and inability to understand the contents of books, which was diagnosed as human papillomavirus vaccination associated with neuropathic syndrome (HANS).


VAERS ID: 620377 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-03-17
Onset:0000-00-00
Submitted: 2015-12-28
Entered: 2015-12-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA147AA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Affect lability, Ageusia, Altered state of consciousness, Amnesia, Back pain, Blood test normal, Borderline personality disorder, Crying, Diarrhoea, Disturbance in attention, Dizziness postural, Dyscalculia, Dyskinesia, Dysmenorrhoea, Dyspnoea, Electroencephalogram normal, Feeling cold, Fibromyalgia, Hallucination, Hallucination, auditory, Headache, Hyperacusis, Hyperkinesia, Hypoaesthesia, Initial insomnia, Laboratory test normal, Learning disorder, Loss of consciousness, Malaise, Menstrual disorder, Mental impairment, Motion sickness, Muscle tightness, Narcolepsy, Nuclear magnetic resonance imaging brain normal, Pain, Pain in extremity, Palpitations, Parosmia, Photophobia, Photosensitivity reaction, Post vaccination syndrome, Respiratory disorder, Restless legs syndrome, Seizure, Somnolence, Temperature regulation disorder, Thrombosis, Thyroid function test normal, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Thrombophlebitis (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN179680

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of transient alteration of awareness in a female subject who received CERVARIX (batch number AHPVA143CA, expiry date unknown), (batch number AHPVA146AA, expiry date unknown) and (batch number AHPVA147AA, expiry date unknown). On 27th August 2011, the subject received the 1st dose of CERVARIX (intramuscular). On 7th December 2011, the 2nd dose was an unknown dose. On 17th March 2012, the 3rd dose was an unknown dose. On 3rd June 2015, unknown after receiving CERVARIX, the subject experienced convulsion (serious criteria hospitalization and GSK medically significant) and movements involuntary (serious criteria hospitalization). On an unknown date, the subject experienced transient alteration of awareness (serious criteria GSK medically significant), narcolepsy (serious criteria GSK medically significant), loss of consciousness (serious criteria GSK medically significant), cerebration impaired (serious criteria GSK medically significant), headache, numbness, tremor finger, numbness of fingers, pain in fingers, pain in extremity, low back pain, malaise, palpitations, dizziness on standing up, diarrhoea, trouble falling asleep, car sickness, photophobia, hyperacusis, altered smell sensation, ageusia, temperature regulation disorder, menstrual disorder, mental concentration decreased, dyscalculia, learning disorder, affect lability, hyperkinesis, restless legs syndrome, respiratory disorder, hallucination, auditory, hallucination and post vaccination syndrome. On an unknown date, the outcome of the transient alteration of awareness, convulsion, movements involuntary, narcolepsy, loss of consciousness, cerebration impaired, numbness, tremor finger, numbness of fingers, pain in fingers, pain in extremity, low back pain, malaise, palpitations, dizziness on standing up, diarrhoea, trouble falling asleep, car sickness, photophobia, hyperacusis, altered smell sensation, ageusia, temperature regulation disorder, menstrual disorder, mental concentration decreased, dyscalculia, learning disorder, affect lability, hyperkinesis, restless legs syndrome, respiratory disorder, hallucination, auditory, hallucination and post vaccination syndrome were unknown and the outcome of the headache was recovering/resolving. It was not reported if the reporter considered the transient alteration of awareness, convulsion, movements involuntary, narcolepsy, loss of consciousness, cerebration impaired, headache, numbness, tremor finger, numbness of fingers, pain in fingers, pain in extremity, low back pain, malaise, palpitations, dizziness on standing up, diarrhoea, trouble falling asleep, car sickness, photophobia, hyperacusis, altered smell sensation, ageusia, temperature regulation disorder menstrual disorder, mental concentration decreased, dyscalculia, learning lability, hyperkinesis, restless legs syndrome, respiratory disorder, hallucination, auditory, hallucination and post vaccination syndrome to be related to CERVARIX. The subject complained of headache after the first CERVARIX vaccination, but improved spontaneously. On 03 June 2015, 3 years and 2 months after the third CERVARIX vaccination, cramp of limb developed at school (the subject was conscious but had involuntary movement). As the involuntary movement did not stopped even after she returned home, she visited a nearby physician, where she was immediately referred to the department of neurology of Hospital. Although she visited the hospital, no neurological problem was detected. The involuntary movement had long persisted thereafter. The subject was hospitalized to the same hospital, and blood tests, head resonance imaging (MRI), and electroencephalogram were conducted, but none of those examinations detected any abnormality. At that time, the attending physician denied epilepsy, and indicated that the symptoms were possibility psychogenic. On 09 July 2015, the subject visited the reporting department. She was still suffering from frequent involuntary movement on a daily basis. Before the onset of involuntary movement, she had a feeling of difficulty in inhaling air, and then involuntary movement and numbness started extending to the body. Although she was conscious, she sometimes lost her consciousness. Twitching of fingertips (tremor-like), numbness and pain developed at least several times a day. She also had headache from morning, pain in extremities and low back pain. She became aware of abnormal tiredness, malaise and palpitation. She began to have dizziness on standing up, which was often associated with headaches. She originally had good bowel movements, but repeatedly experienced occasional diarrhoea. With regard to her sleep, she started experiencing trouble falling asleep, and became unable to wake up in the morning. She managed to wake up by forcing herself to do so. Sudden daytime sleepiness occasionally developed (narcolepsy-like). Dizziness on standing up was intense, but car sickness was mild. She had photosensitivity, sound sensitivity (she was wearing earplugs), and marked hyperosmia. Ageusia was noted. Dysregulation of body temperature was noted. Her sensory temperature was different from that of the family members, and she sometimes suddenly felt cold. Regarding menstruation, the amount of menstrual flow had recently increased abnormally. Period pains became more intense than before. The color of the menstrual flow was brown-red to black, and blood clots were also noted. As for her basal body temperature, although high-temperature phase was present to some extent, it varied greatly. Her mental concentration decreased, and she could not comprehend anything while watching TV. She required more time to do a simple calculation. Although she had originally been poor at kanji characters, she recently forgets this occasionally. She was following the words in books but was not longer able to understand the content of the books. She was emotionally unstable and suddenly started crying and used abusive language when she got excited. Hyperkinesis was noted, and she was walking around her room. When she was sitting, her legs became restless, and she started shaking her legs nervously, which she could not stop on her own will (possible restless legs syndrome). She sometimes lost her consciousness. She also had lost her memories. What she was suffering recently was that, when she was in a daze, she had about 4 children in her mind who were always having quarrels (quiet one, angry one, young one, and speechless one). She had attended school until May, but since the onset of convulsion in June, she had only attended school 1-2 times a week. Physician findings: Muscle tension of the trapezius muscle: Strong. Muscle pain on grasping in the upper-limb muscle: (+). Fibromyalgia (FM) tender points: (+). Findings of blood tests: Inflammatory findings: None. Thyroid function: Normal. Screening of collagen disorder No abnormality. With the series of symptoms from loco-motor impairment which developed 3 years and 2 months after the CERVARIX vaccination including involuntary movement and tremor-like movement, to pain disorder including generalized aching, headache, numbness and pain in fingers, to respiratory disorder causing difficulty in inhaling air, to sleep disorder, to sensory abnormality, to abnormal autonomic nervous system, to abnormal menstruation, and to higher brain dysfunction (possible progression to audiovisual hallucination), human papillomavirus vaccination associated with neuropathic syndrome (HANS) was diagnosed. The features of this case included; a long time interval until the onset, preceding event of involuntary movement, narcolepsy-like symptoms, and progression to audiovisual hallucinations. Multi-layering of clinical symptoms and its context were unique to this case.


VAERS ID: 620391 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-08-23
Onset:2013-04-01
   Days after vaccination:587
Submitted: 2015-12-28
   Days after onset:1001
Entered: 2015-12-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA143BA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abulia, Aggression, Anger, Apathy, Asthenia, Bedridden, Cognitive disorder, Crying, Decreased appetite, Depressed mood, Disturbance in attention, Electroencephalogram normal, Feeling abnormal, Initial insomnia, Intelligence test abnormal, Irritability, Learning disorder, Loss of personal independence in daily activities, Malaise, Memory impairment, Mental impairment, Neuropsychiatric syndrome, Nuclear magnetic resonance imaging brain normal, Post vaccination syndrome, Schizophrenia, Somnolence, Tension, Thought blocking
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (narrow), Depression (excl suicide and self injury) (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN179699

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of schizophrenia in a female subject who received CERVARIX (batch number AHPVA122AA, expiry date unknown), (batch number AHPVA123AA, expiry date unknown) and (batch number AHPVA143BA, expiry date unknown). On 21st February 2011, the subject received the 1st dose of CERVARIX (intramuscular). On 25th March 2011, the 2nd dose was an unknown dose. On 23rd August 2011, the 3rd dose was an unknown dose. In April 2013, an unknown time after receiving CERVARIX, the subject experienced thought blocking, memory impairment and cognitive deterioration. In September 2013, the subject experienced learning disorder, bedridden, decreased appetite, malaise, feeling abnormal, tense and aggression. In January 2014, the subject experienced feeling sad and anger. On an unknown date, the subject experienced schizophrenia (serious criteria GSK medically significant), cerebration impaired (serious criteria GSK medically significant), neuropsychiatric syndrome, trouble falling asleep, hard to awaken, concentration loss, hypobulia and post vaccination syndrome. The subject was treated with ZYPREXA, memantine hydrochloride, theophylline and ROZEREM. On an unknown date, the outcome of the schizophrenia, cerebration impaired, thought blocking, memory impairment, cognitive deterioration, learning disorder, bedridden, decreased appetite, malaise, feeling abnormal, tense, aggression, feeling sad, anger, neuropsychiatric syndrome, trouble falling asleep, hard to awaken, concentration loss, hypobulia and post vaccination syndrome were unknown. It was not reported if the reporter considered the schizophrenia, cerebration impaired, thought blocking, memory impairment, cognitive deterioration, learning disorder, bedridden, decreased appetite, malaise, feeling abnormal, tense, aggression, feeling sad, anger, neuropsychiatric syndrome, trouble falling asleep, hard to awaken, concentration loss, hypobulia and post vaccination syndrome to be related to CERVARIX. In April 2013, after the subject entered to a high school, she experienced feelings that her mind became a complete blank, she was unable to remember things, and she could not recognize one from the other clearly as her mind was being fogged. No physical symptoms including pain and movement involuntary were noted. From around September 2013, her academic grades had dropped rapidly, and she became almost unable to attend school. She stayed in a bed all day and took only a meal a day. She had tiredness and malaise, and lacked energy. She was irritated, and became unable to control herself from yelling and throwing things (although she was not violent to others). From around January 2014, she became completely unable to attend school. When feeling sad at home, she cried or got mad from time to time. The subject visited the department of child psychiatry of the reporting hospital. No abnormality was noted from electroencephalogram and head magnetic resonance imaging (MRI), but decreased processing ability was noted on Wechsler Adult Intelligence Scale (WAIS)-III intelligence test. Although the physician diagnosed schizophrenia and prescribed ZYPREXA, the physician indeed considered symptomatic psychosis. Based on the examinations, the physician considered that systemic lupus erythematosus (SLE) was not present in the context of the symptoms and that no underlying diseases can be found. No improvement of the symptoms was noted with medications. On 30 October 2014, the subject concurrently visited the reporting department. She complained of the symptoms including progression of memory impairment, trouble falling asleep, and hard to awaken. No sun sensitivity or sound sensitivity was noted. Fibromyalgia (FM) point of tenderness was negative. No tenderness muscle was noted. The subject had normal calculation ability but lacked concentration and motivation. (Avolition was noted, while she was active to club activities, studies and enrichment lessons all before the vaccination. She complained of tiredness and malaise. She was always in a daze and her mind was being fogged. She reported that she can no longer think clearly. No dizziness on standing up, constipation or diarrhoea was noted. She had regular menstruations without period pains and altering of the color of the menstrual flow. ZYPREXA was discontinued. Irritability had subsided with the start of memantine 10 mg. When memantine was reduced to 5 mg and theophylline was added, she regained motivation and became able to read books. She was placed under observation with an increased theophylline dose to 100 mg. The trouble fallings asleep showed an improving trend with ROZEREM. Physical findings: FM point of tenderness: (-); Tenderness muscle: (+-); Chest and abdomens: No abnormal findings. Findings of blood tests: Inflammatory findings: None; Thyroid function: Normal; Screening of collagen disorder: No abnormality. Although no pain disorder developed after the vaccination, progression of the symptoms including tiredness, malaise, hypobulia, memory impairment and sleep disorder was noted. ZYPREXA, which was indicated for mood disorder and schizophrenia, was ineffective. Drugs including theophylline and memantine were effective for improving the symptoms. Human papillomavirus vaccination associated with neuropathic syndrome (HANS) was diagnosed. This case was considered to involve predominant manifestation of higher brain dysfunction.


VAERS ID: 620396 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-08-01
Onset:0000-00-00
Submitted: 2015-12-28
Entered: 2015-12-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA138AB / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Asthenia, Autonomic nervous system imbalance, Blood test normal, Cognitive disorder, Constipation, Diarrhoea, Disturbance in attention, Dizziness postural, Dysgraphia, Dysmenorrhoea, Feeling hot, Fibromyalgia, Frustration tolerance decreased, Gait disturbance, Headache, Hot flush, Hyperhidrosis, Hypoaesthesia, Initial insomnia, Listless, Loss of personal independence in daily activities, Malaise, Memory impairment, Menstruation irregular, Mental impairment, Mood altered, Myalgia, Neuropathy peripheral, Palpitations, Photophobia, Photosensitivity reaction, Poor quality sleep, Post vaccination syndrome, Sleep disorder, Somnolence, Sympathicotonia, Temperature regulation disorder, Thyroid function test normal, X-ray normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Fertility disorders (broad), Hypersensitivity (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN179679

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of cerebration impaired in a female subject who received CERVARIX (batch number AHPVA100BC, expiry date unknown) and (batch number AHPVA138AB, expiry date unknown). On 1st February 2011, the subject received the 1st dose of CERVARIX (intramuscular). On 1st March 2011, the 2nd dose was an unknown dose. On 1st August 2011, the 3rd dose was an unknown dose. In 2011, several months after receiving CERVARIX, the subject experienced arthralgia, difficulty in walking, headache and dizziness on standing up. On an unknown date, the subject experienced cerebration impaired (serious criteria GSK medically significant), post vaccination syndrome, joint tenderness, tenderness muscle, fibromyalgia syndrome, autonomic dysfunction, malaise, sympathicotonia, sweating increased palms, palpitations, temperature regulation disorder, hot flush, feeling hot, constipation, diarrhoea, abdominal pain, numbness, menses painful, irregular menstrual cycle, sleep disorder, trouble falling asleep, light sleep, hard to awaken, mental concentration decreased, listless, mood altered, memory impairment, dysgraphia, cognitive disorder and photophobia. On an unknown date, the outcome of the cerebration impaired, post vaccination syndrome, hot flush, feeling hot constipation, diarrhoea, abdominal pain, menses painful, irregular menstrual cycle, mental concentration decreased, listless, mood altered, memory impairment and dysgraphia were not recovered/not resolved and the outcome of the arthralgia, difficulty in walking, headache, joint tenderness, tenderness muscle, fibromyalgia syndrome, autonomic dysfunction, dizziness on standing up, malaise, sympathicotonia, sweating increased palms, palpitations, temperature regulation disorder, numbness, sleep disorder, trouble falling asleep, light sleep, hard to awaken, cognitive disorder and photophobia were unknown. It was not reported if the reporter considered the cerebration impaired, post vaccination syndrome, arthralgia, difficulty in walking, headache, joint tenderness, tenderness palms, palpitations, temperature regulation disorder, hot flush, feeling hot, constipation, diarrhoea, abdominal pain, numbness, menses painful, irregular menstrual cycle, sleep disorder, trouble falling asleep, light sleep, hard to awaken, mental concentration decreased, listless, mood altered, memory impairment, dysgraphia, cognitive disorder and photophobia to be related to CERVARIX. In 2011, the subject began to have bilateral gonalgia about 3 months after the second HPV vaccination. The subject visited an orthopedic clinic, where blood tests and X-ray photography showed no abnormality. The gonalgia, especially in the inner sides of the knees, occurred almost every day, which often made the subject difficult to walk. At the same time, the subject also began to have headache (which sometimes became paroxysmal and violent) and dizziness on standing up. At that time, these symptoms were considered to be attributed to her club (track club) activities. However, the cause of the pain was not identified, although the subject had visited several clinics. Her menstruation was regular without cessation, and no change in color of the menstrual blood was noted. Her menstruation was not always painful, but sometimes became intense, for which she often required bed rest. She had no photosensitivity or hyperacusia. On an unknown date, headache and dizziness on standing up developed. No numbness or palpitations was noted. She sat out during gym class because of the pain when she was in junior high school. These symptoms were persistent, which forced her quit the club activities. on 13 November 2014, she visited Hospital A, the gonalgia was persisting and she had headache, dizziness on standing up, severe malaise, sweaty hands (drenched palms: excessive sympathetic nerve activity), palpitations and sleep disorders (trouble falling asleep an feeling of a lack of deep sleep), and she became hard to wake up in the morning. On an unknown date, the photosensitivity was so severe that she felt dazzling of an external light (sunlight). In summer 2015, she could not control her body temperature, and wore a long-sleeved shirt on a scorching hot day. As of 17 December 2015, her menstruation became irregular and was associated with severe painful menses every time. The menstrual blood became black with clots. Her mental concentration decreased and she had low energy. She could do arithmetic. However, she often could not recall characters. She also had memory disorder and often read books over and over again, but did not understand the contents. Therefore, she was worrying about the entrance exams. She had no hyperacusia. Her family member told her that her mood dramatically changed and that she experienced more frustration. She also had hot flush, and suffered from constipation and diarrhoea alternately. The diarrhoea was accompanied by abdominal pain. She attended school, enduring the pain. She had to participate in gym classes for credits, enduring the pain. Blood tests/X-ray photography: No abnormality Physical examinations: No gonarthritis. Tenderness in the shoulder joints. Muscle pain on grasping. Fibromyalgia (FM) tender points: Positive No abnormal findings in the chest and abdomen. Blood tests: No inflammatory findings Thyroid function tests: No abnormality Screening for collagen disorder: No abnormality The subject''s symptoms progressed to pain disorders including gonalgia, headache and myalgia, followed by malaise and numbness, followed by menstruation abnormal, followed by sensory aberrations including photosensitivity, followed by autonomic dysfunctions, including palpitations, dizziness on standing up and recurrent constipation/ diarrhoea, and then higher cerebral dysfunctions including memory disorder/ agnosia, and were becoming increasingly multi-layered. The symptoms were further evolving and worsening over time. Accordingly, HPV vaccination associated with neuropathic syndrome was diagnosed.


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