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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: 603044 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-05-29
Onset:2014-06-13
   Days after vaccination:15
Submitted: 2015-10-16
   Days after onset:490
Entered: 2015-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Asthenia, Back pain, Diplegia, Guillain-Barre syndrome, Immediate post-injection reaction, Immunoglobulin therapy, Mental disorder
SMQs:, Peripheral neuropathy (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations: Guillain Barre~HPV (Cervarix)~2~10.83~Patient
Other Medications: Prednisone adverse reaction. Acute disseminated encephalomyelitis
Current Illness: When the vaccine did not have disease
Preexisting Conditions: Asthmatic bronchitis
Allergies:
Diagnostic Lab Data: Paralysis of lower limbs and upper limbs ascending treated with prednisone high medical hospital. Psychological disorder.
CDC Split Type:

Write-up: May 29, 2104 second HPV vaccine doses, adverse reaction immediate loss of strength in both piernasl pain in the lower back, applies CERVARIX HPV June 2 lumbar MRI is requested. June 12 enters Hospital a CD. June 13 ascending paralysis symmetrical, medicated with prednisone 5 days after regaining strength sequel sagging hip and left leg. Psychological disorder discharged from the hospital on June 19. It is particularly applied immunoglobulin reacts positively. The doctor suspected Guillain-Barre syndrome.


VAERS ID: 739981 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-10-26
Entered: 2015-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Ambidexterity, Computerised tomogram head normal, Cough, Disuse syndrome, Headache, Hypoaesthesia, Intelligence test, Laboratory test abnormal, Malaise, Mental impairment, Muscular weakness, Pain, Post vaccination syndrome, Prosopagnosia, Pyrexia, Radioisotope scan normal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: On an unknown date: Head computerized tomograph (CT)/magnetic resonance imaging (MRI): No abnormality; Cerebral perfusion scintigraphy: Decreased blood flow at the inferior surface of the occipital temporal lobe. Raven''s colored progressive materices (RCPM): 34/36. Miyake paire-associate word learning test: Related pairs of words: 9-10, and unrelated pairs of words: 5-10. Wechsler adult intelligence scale (WAIS-III): verval IQ (VIQ), 105; performance IQ (PIQ), 97; and full-scale IQ (FIQ), 102. Visual perception test for agnosia (VPTA): Poor results were noted only for face recognition, but no problems in visuoperceptual function, recognition of object, picture, color and symbol, and topographical orientation were noted. Deep test for face recognition: Loss of acquaintance.
CDC Split Type: JP2015JPN141413

Write-up: This case was reported in a literature article and described the occurrence of cerebration impaired in a 20-year-old female subject who received CERVARIX. On an unknown date, the subject received the 3rd dose of CERVARIX (intramuscular). On an unknown date, an unknown time after receiving CERVARIX, the subject experienced cerebration impaired (serious criteria GSK medically significant), disuse syndrome (serious criteria hospitalization), post vaccination syndrome, prosopagnosia, malaise, pyrexia, cough, numbness, headache, generalised aching and muscular weakness. On an unknown date, the outcome of the cerebration impaired, disuse syndrome, post vaccination syndrome, prosopagnosia, malaise, pyrexia, cough, numbness, headache, generalised aching and muscular weakness were unknown. It was not reported if the reporter considered the cerebration impaired, disuse syndrome, post vaccination syndrome, prosopagnosia, malaise, pyrexia, cough, numbness, headache, generalised aching and muscular weakness to be related to CERVARIX. The subject was ambidexterity. The subject went on to university, but experienced malaise, pyrexia, cough and numbness. In May (in the year reported as "X"), the subject experienced higher cerebral dysfunction with prosopagnosia, and had difficulty with recognizing faces. The subject had visited multiple medical institutions. In September (in the year reported as "X+2"), human papillomavirus vaccination (HPV) associated with neuropathic syndrome was diagnosed. On an unknown date, the subject had often required bed rest due to headache and generalized pain, and ended up having disuse syndrome. The subject experienced muscular weakness caused by the disuse syndrome. The subject suffered from intermittent generalized pain and numbness. In December (in the year reported as "X+2"), the subject was hospitalized. On an unknown date, the subject visited Hospital for rehabilitation on referral from Hospital. On an unknown date, the subject had difficulty with recognizing medical staff members'' faces, and often mentioned the characteristics of them such as the hairstyles, whether or not wearing glasses, and the types of clothes. Moreover, the subject reported that the subject was also difficult to recognize the characters'' faces in the subject''s favorite TV dramas other than that of the main character, and poorly understood the stories. The subject had no problems in recognizing things, literature and landscapes, but only in recognizing faces. As of 19 October 2015, the subject was on treatment at Hospital again. Results of relevant tests and procedures associated with the diagnosis: On an unknown date: Head computerized tomograph (CT)/magnetic resonance imaging (MRI): No abnormality. Cerebral perfusion scintigraphy: Decreased blood flow at the inferior surface of the occipital temporal lobe. Raven''s colored progressive materices (RCPM): 34/36. Miyake paire-associate word learning test: Related pairs of words: 9-10, and unrelated pairs of words: 5-10. Wechsler adult intelligence scale (WAIS-III): verval IQ (VIQ), 105; performance IQ (PIQ), 97; and full-scale IQ (FIQ), 102. Visual perception test for agnosia (VPTA): Poor results were noted only for face recognition, but no problems in visuoperceptual function, recognition of object, picture, color and symbol, and topographical orientation were noted. Deep test for face recognition: Loss of acquaintance.


VAERS ID: 615456 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-07-28
Onset:0000-00-00
Submitted: 2015-11-04
Entered: 2015-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA149CA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arrhythmia, Electroencephalogram normal, Irritable bowel syndrome, Mental impairment, Muscular weakness, Neuropathy peripheral, Nuclear magnetic resonance imaging brain normal, Photophobia, Post vaccination syndrome, Single photon emission computerised tomogram abnormal, Sleep disorder, Vaccination complication
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Cardiac arrhythmia terms, nonspecific (narrow), Noninfectious diarrhoea (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? 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: JP2015JPN153787

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of post vaccination syndrome in a female subject who received CERVARIX (batch number AHPVA149BA, expiry date unknown) and batch number AHPVA149CA, expiry date unknown). On 20th December 2011, the subject received the 1st dose of CERVARIX (intramuscular). On 28th January 2012, the 2nd dose was an unknown dose. On 28th July 2012, the 3rd dose was an unknown dose. In 2011, less than a month after receiving CERVARIX, the subject experienced irritable bowel syndrome and arrhythmia. On an unknown date, the subject experienced post vaccination syndrome (serious criteria hospitalization), thinking reduced (serious criteria GSK medically significant), sleep disorder, photophobia and muscular weakness. On an unknown date, the outcome of the post vaccination syndrome was not recovered/not resolved and the outcome of the thinking reduced, irritable bowel syndrome, arrhythmia, sleep disorder, photophobia and muscular weakness were unknown. The reporter considered the post vaccination syndrome to be related to CERVARIX. It was not reported if the reporter considered the thinking reduced, irritable bowel syndrome, arrhythmia, sleep disorder, photophobia and muscular weakness to be related to CERVARIX. In around 2011, after the CERVARIX vaccination, the subject experienced irritable bowel syndrome and arrhythmia. On an unknown date, the subject experienced symptoms including thinking reduced, sleep disorder, sun sensitivity and muscle weakness, for which the subject visited the reporting department. The subject had a normal electroencephalogram. Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) revealed no significant change in the subject''s brain. However, cerebral perfusion single photon emission computed tomography (SPECT) revealed decreased blood flow in regions including occipital lobe. Various symptoms were observed, and were diagnosed as adverse reactions to the cervical cancer vaccination (human papillomavirus (HPV) vaccination associated with neuro-immunopathic syndrome [HANS]). The subject was being treated. On an unknown date: Electroencephalogram: normal. Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA): no significant change in the subject''s brain. Cerebral perfusion single photon emission computed tomography (SPECT): decreased blood flow in regions including occipital lobe.


VAERS ID: 620114 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-02-29
Onset:2015-10-01
   Days after vaccination:1310
Submitted: 2015-12-22
   Days after onset:82
Entered: 2015-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA146CD / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Depressed mood, Dysmenorrhoea, Headache, Loss of personal independence in daily activities, Malaise, Mental impairment, Photophobia, Sensory disturbance, Sleep disorder, Stress
SMQs:, Peripheral neuropathy (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow)

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? Yes, 20 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN177684

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of cerebration impaired in a adolescent female subject who received CERVARIX (batch number AHPVA138BA, expiry date unknown), (batch number AHPVA145AA, expiry date unknown) and (batch number AHPVA146CD, expiry date unknown). On 22nd August 2011, the subject received the 1st dose of CERVARIX (intramuscular). On 26th September 2011, the 2nd dose was an unknown dose. On 29th February 2012, the 3rd dose was an unknown dose. In October 2015, several years after receiving CERVARIX, the subject experienced cerebration impaired (serious criteria hospitalization and GSK medically significant), photophobia (serious criteria hospitalization), malaise (serious criteria hospitalization), sleep disorder (serious criteria hospitalization), depressed mood (serious criteria hospitalization), activities of daily living impaired (serious criteria hospitalization), stress, sensory disturbance and weakness. On an unknown date, the subject experienced headache (serious criteria hospitalization) and menses painful. On an unknown date, the outcome of the cerebration impaired, headache, photophobia, malaise, sleep disorder and depressed mood were not recovered/not resolved and the outcome of the activities of daily living impaired, menses painful, stress, sensory disturbance and weakness were unknown. It was unknown if the reporter considered the cerebration impaired, headache, photophobia, malaise, sleep disorder and depressed mood to be related to CERVARIX. It was not reported if the reporter considered the activities of daily living impaired, menses painful, stress, sensory disturbance and weakness to be related to CERVARIX. On an unknown date, headache and period pains developed after the vaccination. The subject managed to maintain her living, and was able to attend school as well. From 24 November 2015 to 14 December 2015, the subject was hospitalized. As of 14 December 2015, the outcome of higher brain dysfunction, headache, photophobia, malaise, sleep disorder and depression was unresolved. The outcome of other symptoms was unknown. Comments from the reporter: No obvious abnormal finding was noted. The symptoms were somewhat similar to other patients. The fact that the subject experienced various symptoms was consistent with the features of adverse reactions to CERVARIX. However, it had been a long time since the vaccination, which weakened a possible association.


VAERS ID: 620326 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-11-05
Onset:2011-11-05
   Days after vaccination:0
Submitted: 2015-12-27
   Days after onset:1513
Entered: 2015-12-29
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA149AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Autonomic nervous system imbalance, Chills, Constipation, Depressive symptom, Diarrhoea, Disturbance in attention, Dizziness, Dizziness postural, Dyspnoea, Fall, Fatigue, Fibromyalgia, Folliculitis, Gait disturbance, Headache, Inflammatory marker test, Learning disorder, Loss of consciousness, Malaise, Memory impairment, Menstrual disorder, Mental impairment, Motion sickness, Myalgia, Narcolepsy, Nasal congestion, Nausea, Neuropathy peripheral, Pain, Pain of skin, Palpitations, Photophobia, Post vaccination syndrome, Pruritus, Pyrexia, Single photon emission computerised tomogram abnormal, Sleep disorder, Thyroid function test normal, Tremor, Urticaria
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (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? 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: A201115328

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of loss of consciousness in a 16-year-old female subject who received Human papilloma type 16 + 18 vaccine (batch number AHPVA149AA, expiry date unknown). On 5th November 2011, the subject received Human papilloma type 16 +18 vaccine (intramuscular) .5 ml. On 5th November 2011, unknown after receiving Human papilloma type 16 +18 vaccine, the subject experienced pain, dyspnoea, palpitations, feeling queasy, myalgia, arthralgia, headache, fatigue, shaking of hands and pyrexia. On 6th November 2011, the subject experienced tremor. In August 2013, the subject experienced malaise and gait disturbance. On an unknown date, the subject experienced loss of consciousness (serious criteria GSK medically significant), narcolepsy (serious criteria GSK medically significant) cerebration impaired (serious criteria GSK medically significant), dizziness, coxalgia, menstrual disorder, memory impairment, chills, fall, urticaria, folliculitis, pain of skin, itchy skin, sleep disorder, dizziness on standing up, car sickness, diarrhoea, constipation, concentration ability impaired, learning disorder, photophobia, nasal congestion, autonomic dysfunction, post vaccination syndrome and depressive symptom. On an unknown date, the outcome of the loss of consciousness, narcolepsy, cerebration impaired, pyrexia, coxalgia, chills, malaise, gait disturbance, fall and depressive symptom were unknown and the outcome of the pain, dyspnoea, palpitations, feeling queasy, myalgia, arthralgia, headache, fatigue, dizziness, shaking of hands, tremor, menstrual disorder, memory impairment, urticaria, folliculitis, pain of skin, itchy skin, sleep disorder, dizziness on standing up, car sickness, diarrhoea, constipation, concentration ability impaired, learning disorder, photophobia, nasal congestion, autonomic dysfunction and post vaccination syndrome were not recovered/not resolved. It was not reported if the reporter considered the loss of consciousness, narcolepsy, cerebration impaired, dizziness, shaking of hands, pyrexia, tremor, coxalgia, menstrual disorder, memory impairment, chills, malaise, gait disturbance, fall, urticaria, folliculitis, pain of skin, itchy skin, sleep disorder, dizziness on standing up, car sickness, diarrhoea, constipation, concentration ability impaired, learning disorder, photophobia, nasal congestion, autonomic dysfunction, post vaccination syndrome and depressive symptom to be related to Human papilloma type 16 +18 vaccine. It was unknown if the reporter considered the pain, dyspnoea, palpitations, feeling queasy, myalgia, arthralgia, headache and fatigue to be related to Human papilloma type 16 +18 vaccine. On 06 November 2011, the subject visited the medical institution where the vaccination was given, and was told by the physician who gave the vaccination that the symptoms were due to common cold not adverse reactions. When she received a course of infusions, shaking of hands and the entire body worsened further. The symptoms were so intense that a nurse asked the subject if she needed an ambulance. Subsequently, headache and giddiness disturbing self-walking developed, and she was absent from school for about 2 weeks. Pain in right hip also developed, which made it hard for the subject to walk upstairs. In addition, abnormal menstruation (periods were irregular and amenorrhoea was noted depending on a month) and decreased memory ability were noted. In 2012, as the symptoms did not improve, the subject visited a nearby internal medicine department. However, no improvement in the symptoms was noted. In March 2012, although the subject visited the department of otolaryngology on referral for giddiness, no otolaryngologic abnormality was found, nor the symptoms improved. Shaking of hands and chills developed many times a day. In August 2013, headache, giddiness, tiredness and malaise were so intense that the subject could not walk. During this period, she fell in a train, and also fell from the stairs after losing her consciousness. Sudden onset of sleep also developed (narcolepsy). She visited the giddiness outpatient department of Hospital, and regularly visited the hospital once in three months for rehabilitations. As of December 2014, intense giddiness, headache, daily shaking of either the neck, shoulders or hands, abnormal menstruation and decreased memory ability were noted. In addition, the subject felt heavy with her body, and continued suffering from intense difficulty in moving. Urticaria and folliculitis also started developing, and she continued visiting the dermatology department of Hospital. She could not sleep at night due to pain and itching of skin. Dizziness on standing up and car sickness were intense, and diarrhoea and constipation also repeatedly developed. She was not able to wake up in the morning due to tiredness and giddiness. Her mental concentration had been decreased, and she also had memory impairment, especially with recent memories. She made more mistakes in simple calculations, and was unable to remember and write characters. She stopped reading books, as she could not understand the contents. She was even unable to remember what was written two lines earlier. She was able to recognize faces of her friends and family members. Her academic grades dropped. Photosensitivity was observed, and she often covered her eyes with her hands or arms. Sound sensitivity was not noted, and she rather found it difficult to hear sounds and voices. Nasal congestion was persisting. She managed to attend university, but was absent at least 2 days a week. She became absent from university during menstruation, as her condition was particularly worse. The symptoms worsened at times of menstruation. She had intense period pains. Results of relevant tests and procedures associated with the diagnosis: On an unknown date; Physical findings; Fibromyalgia (FM) point of tenderness: All positive. Muscle tenderness: Present. Chest and abdomens: No abnormal findings. Findings of blood tests: Inflammatory: None. Thyroid function: Normal. Screening of collagen disorder: Normal. Single photon emission computed tomography (SPECT): Decreased blood flow in cingulate gyrus, medulla oblongata and cerebellum. This case involved obvious progression and multi-layering of the symptoms in a short period of time from pain disorders, to tiredness and malaise, to involuntary movement, giddiness and syncope (loco-motor disorder), to abnormal menstruation, to sensory disturbance, to narcolepsy autonomic nervous system disorders, and to higher brain dysfunction, which was typical human papillomavirus vaccination associated with neuropathic syndrome (HANS).


VAERS ID: 620345 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-07-07
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 AHPVA156AB / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Antinuclear antibody negative, Asthenia, Autonomic nervous system imbalance, Back pain, Cognitive disorder, Computerised tomogram normal, Constipation, Decreased appetite, Disturbance in attention, Dizziness postural, Dyscalculia, Dysstasia, Fall, Feeling hot, Gait disturbance, Headache, Hyperacusis, Hypersomnia, Inflammatory marker test, Initial insomnia, Laboratory test normal, Loss of personal independence in daily activities, Malaise, Memory impairment, Menstrual disorder, Mental impairment, Motor dysfunction, Neuropathy peripheral, Post vaccination syndrome, Premenstrual syndrome, Pyrexia, Slow speech, Spinal X-ray normal, Temperature regulation disorder, Urinary incontinence, Vaccination site pain, Vaccination site swelling, Visual acuity reduced transiently
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (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), Glaucoma (broad), Optic nerve disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), 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: From May to June 2014; Cervical X-ray photography (X-P); No abnormal findings; Summer in 2014; Computerized tomogram (CT): No abnormal findings; On an unknown date; Physical examinations: Objective neurological findings included no abnormal tendon reflex, no pathological reflex, or any noteworthy findings. Fibromyalgia (FM)tender points: (+) Muscle pain on grasping: (+); No findings of arthritis; Findings of blood tests: No inflammatory findings; Screening of collagen disorder: Anti-nuclear antibody, 40-fold; anti-ribonucleoprotein (RNP) antibody, (-); and anti-Ro (SS-A) antibody, (-)
CDC Split Type: JP2015JPN179695

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 AHPVA138AC, expiry date unknown), (batch number AHPVA143CA, expiry date unknown) and (batch number AHPVA156AB, expiry date unknown). On 7th July 2011, the subject received the 1st dose of CERVARIX (intramuscular). On 26th August 2011, the 2nd dose was an unknown dose. On 24th February 2012, the 3rd dose was an unknown dose. In July 2011, less than a month after receiving CERVARIX, the subject experienced vaccination site swelling and vaccination site pain. In January 2013, the subject experienced pyrexia, headache, malaise, temporal headache and low back pain. In April 2013, the subject experienced urinary incontinence. On an unknown date, the subject experienced cerebration impaired (serious criteria GSK medically significant), post vaccination syndrome, trouble falling asleep, hypersomnia, difficulty in standing, decreased ability to grasp, stumbling, fall, weakness, concentration loss, cognitive deterioration, hyperacusis, menstrual disorder, premenstrual syndrome, decreased appetite, constipation, dyscalculia, bradylalia, memory impairment, dizziness on standing up, temperature regulation disorder, feeling hot, autonomic dysfunction, visual acuity reduced transiently and dizziness on standing up, temperature regulation disorder, feeling hot, autonomic dysfunction, visual acuity reduced transiently and dizziness. In 2013, the outcome of the pyrexia was recovered/resolved. On an unknown date, the outcome of the cerebration impaired, post vaccination syndrome, vaccination site swelling, vaccination site pain, headache, malaise, temporal headache, low back pain, urinary incontinence, trouble falling asleep, hypersomnia, difficulty in standing, decreased ability to grasp, stumbling, fall, weakness, concentration loss, cognitive deterioration, hyperacusis, menstrual disorder, premenstrual syndrome, decreased appetite, constipation, dyscalculia, bradylalia, memory impairment, dizziness on standing up, temperature regulation disorder, feeling hot, autonomic dysfunction, visual acuity reduced transiently and dizziness were unknown. It was not reported if the reporter considered the cerebration impaired, post vaccination syndrome, vaccination site swelling, vaccination site pain, pyrexia, headache, malaise, temporal headache, low back pain, urinary incontinence, trouble falling asleep, hypersomnia, difficulty in standing, decreased ability to grasp, stumbling, fall, weakness, concentration loss, cognitive deterioration, hyperacusis, menstrual disorder, premenstrual syndrome, decreased appetite, constipation, dyscalculia, bradylalia, memory impairment, dizziness on standing up, temperature regulation disorder, feeling hot, autonomic dysfunction, visual acuity reduced transiently and dizziness to be related to CERVARIX. Before the vaccination: The subject was originally healthy with nothing noteworthy. She had no history of hospitalization. She had participated actively in event from elementary school to the first year of junior high school, and an archery club after entering to high school. Her academic performance was in a top class among the same year students (she had always been listed in top 20). After the second and third vaccinations, the vaccinations sites were painful and extremely swollen. Around January 2013, she had pyrexia for about a week, and intense headache and tiredness persisted. Although a local physician did not point out any abnormality, headache and abnormal tiredness persisted even after she became afebrile. Headache developed every early morning, sometimes at the temple and sometimes the entire head. Headache worsened especially with bad and glacial weather. Low back pain also worsened. Around April 2013, she had urinary incontinence (just once) of unknown reason. On an unknown date, trouble falling asleep was noted, for which she took a sleep agent. She also had excessive sleep and sometimes fell asleep during daytime frequently. She was extraordinarily tired up, on awakening, and became unable to wake up in the morning. She dropped things from her hands more frequently than before, and tended to stumble and fall when walking. Weakness developed occasionally. In the third year of high school, mental concentration was decreased, and she was no longer able to dedicate herself to studies. She became unable to understand the contents of books when reading. She visited a counselor for these symptoms in summer break. On an unknown date, she had no photosensitivity, while sound sensitivity occurred. No menstrual irregularity was noted, but the color of menstrual flow was sometimes brown to blackish, and she noticed some blood clots. Malaise, tiredness, and hot flush intensified before periods. She did not have diarrhoea but had intense constipation. She started making mistakes and took long for simple calculations. She had more difficulty in findings words to speak. She could not keep or recall what she had learnt (memory impairment). Dizziness on standing up and dysregulation of temperature were noted. She always felt feverish with her body, and also noticed hot flush. She visited the attending physician irregularly. It was reported that headache worsened after her head was hit with a ball in a physical education class. Around May to June 2014, she visited the outpatient department. In summer 2014, she visited the neurosurgery department. Status of school attendance: She attended school with occasional tardy depending on her physical condition. As the condition varied daily, she sometimes had perfect attendance for a week with no tardy, but also had 2-3 times of tardy in a week. She was absent from school about once a month. Results of relevant tests and procedures associated with the diagnosis: From May to June 2014; Cervical X-ray photography (X-P); No abnormal findings; Summer in 2014; Computerized tomogram (CT): No abnormal findings; On an unknown date; Physical examinations: Objective neurological findings included no abnormal tendon reflex, no pathological reflex, or any noteworthy findings. Fibromyalgia (FM)tender points: (+) Muscle pain on grasping: (+); No findings of arthritis; Findings of blood tests: No inflammatory findings; Screening of collagen disorder: Anti-nuclear antibody, 40-fold; anti-ribonucleoprotein (RNP) antibody, (-); and anti-Ro (SS-A) antibody, (-). Although generalized aching was absent after the HPV, multi-layering of symptoms was noted from intense headache that persisted from early morning, abnormal tiredness, and low back pain, to abnormal menstruation, to sleep disorder, to sensory disturbance including sound sensitivity, to autonomic dysfunction including dizziness on standing up, persistent constipation and dysregulation of temperature, and to higher brain dysfunction including decreased mental concentration, acalculia, and memory impairment, for which human papillomavirus vaccination associated with neuropathic syndrome HANS was diagnosed.


VAERS ID: 620346 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-06-27
Onset:2013-09-01
   Days after vaccination:66
Submitted: 2015-12-28
   Days after onset:848
Entered: 2015-12-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA165BA / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Arthralgia, Audiogram abnormal, Autonomic nervous system imbalance, Back pain, Chest discomfort, Deafness, Dizziness, Dizziness postural, Dysmenorrhoea, Ear pain, Fall, Fibromyalgia, Gait disturbance, Headache, Hyperacusis, Hyperventilation, Hypoacusis, Laryngeal discomfort, Listless, Loss of personal independence in daily activities, Malaise, Memory impairment, Menstrual disorder, Menstruation irregular, Mental impairment, Middle insomnia, Motion sickness, Muscle tightness, Myalgia, Nausea, Neuropathy peripheral, Nuclear magnetic resonance imaging normal, Pain, Panic reaction, Pharyngitis, Post vaccination syndrome, Pyrexia, Respiratory disorder, Restlessness, Rheumatoid factor negative, Sensation of foreign body, Sensory disturbance, Sleep disorder, Syncope, Temperature regulation disorder, Thyroid function test normal, Tinnitus
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Akathisia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (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), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Respiratory failure (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? 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: JP2015JPN179688

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 AHPVA164BB, expiry date unknown), (batch number AHPVA165BA, expiry date unknown) and (batch number AHPVA164BB, expiry date unknown). On 30th May 2013, the subject received the 1st dose of CERVARIX (intramuscular). On 27th June 2013, the 2nd dose was an unknown dose. On 17th December 2013, the 3rd dose was an unknown dose. In September 2013, several months after receiving CERVARIX, the subject experienced headache. In January 2014, the subject experienced deafness (serious criteria GSK medically significant), tinnitus and hypoacusis. On an unknown date, the subject experienced cerebration impaired (serious criteria medically significant), post vaccination syndrome, malaise, anxiety symptoms NOS, back pain, feeling queasy, myalgia, arthralgia, chest discomfort, respiratory disorder, slight fever, temperature regulation disorder, headache, sleep disorder, nocturnal awakening, laryngeal discomfort, pharyngitis, hyperpnoea, panic reaction, hyperacusis, ear pain, dizziness on standing up, motion sickness, menses painful, irregular menstrual cycle, menstrual disorder, tenderness muscle, muscle tightness, fall, sensory disturbance and autonomic dysfunction. The subject was treated with CLEAMINE, Chinese medicine, NAUZELIN and HORIZON. On an unknown date, the outcome of the cerebration impaired, deafness, post vaccination syndrome, headache, tinnitus, hypoacusis, malaise, anxiety symptoms NOS, back pain, feeling queasy, myalgia arthralgia, chest discomfort, respiratory disorder, slight fever, temperature regulation disorder, headache, sleep disorder, nocturnal awakening, laryngeal discomfort, pharyngitis, hyperpnoea, panic reaction, hyperacusis, ear pain, dizziness on standing up, motion sickness, menses painful, irregular menstrual cycle, menstrual disorder, tenderness muscle, muscle tightness, fall, sensory disturbance and autonomic dysfunction were unknown. It was not reported if the reporter considered the cerebration impaired, deafness, post vaccination syndrome, headache, tinnitus, hypoacusis, malaise, anxiety symptoms NOS, back pain, feeling queasy, myalgia, arthralgia, chest discomfort, respiratory disorder, slight fever, temperature regulation disorder, headache, sleep disorder, nocturnal awakening, laryngeal discomfort, pharyngitis, hyperpnoea, panic reaction, hyperacusis, ear pain, dizziness on standing up, motion sickness, menses painful, irregular menstrual cycle, menstrual disorder, tenderness muscle, muscle tightness, fall, sensory disturbance and autonomic dysfunction to be related to CERVARIX. The subject was given 3 doses of the vaccine in her first year of middle school. In around September 2013, after the second vaccination, headache developed. The subject was prescribed analgesics and had been followed up by a pediatric clinic that had vaccinated the subject. CLEAMINE, Yokukansan (Chinese herbal medicine) and NAUZELIN were prescribed. In around January 2014, the subject experienced headache more frequently. In addition, she had tinnitus and her hearing decreased. The subject visited a Ontological Clinic C where she underwent audiometric tests which revealed only mild hearing impaired, and the physician considered that she may have had stress-related hearing loss. Oral medications were prescribed. However, there had been no improvement with those medications, and the subject had not visited the ontological clinic since then. In February 2014, the subject visited the headache outpatient service of Hospital D, where an magnetic resonance imaging (MRI) was performed which revealed no obvious organic abnormality. The subject was instructed to continue oral medicines. After that, the symptoms were still persisting and she also experienced listlessness/malaise, and she found it difficult to attend the junior high school. She had always felt anxious. In September 2015, the subject visited Clinic E. HORIZON was prescribed, which did not improve her anxiety symptoms. Since then, she had not visited the clinic. On 15 October 2015, the subject visited the reporting hospital. The headache and low back pain had had waxed and waned over, however, no improvement of these symptoms had been noted for the last more than a year and a half. The headache was sometimes associated with queasy. The subject remained laid down because pains (unknown whether in muscles or joints) developed when the subject moved a bit. She had low back/back pain even though she was at rest. Her anxious feeling was severe and she was restless. The subject had chest pressure sensation and sometimes found it difficult to breathe with feeling she could not get air. The subject had not experienced gait disturbance/memory impairment until now. At the first visit, the subject collapsed in a room for blood sampling at the time of blood collection. At the time of her outpatient visit, mild fever of around 37 degrees C was noted. She always wore a parka coat even in summer, and the family members thought that the subject may have failed to control her body temperature. The subject had headache from waking up, which was as if someone was gradually squeezing her head, and associated with queasy. It could occur paroxysmally. The subject had sleep disorder. The subject barely experienced trouble falling asleep, but suffered from frequently interrupted sleep. She always felt a lump in her throat, which was diagnosed as pharyngitis by a local physician. She experienced hyperpnea if the feeling that she could not get air got worse. and she had been taken to the nurse''s office in the school because of a panic attack. No photosensitivity was noted. The subject had severe auditory hyperacuity with tinnitus and ear pain. The subject was unable to travel by airplane because she would have troubles with her ears during an airplane flight. Her lightheadedness became more severe than before and she also had severe motion sickness in a train. The period pains were more severe than before, and her menstruation became irregular and was associated with thick blood clots. Status of attending school: The subject was found to be difficult to commute to the junior high school and to attend the classes because of the headache and back pain. Results of relevant tests and procedures associated with the diagnosis: Physical findings: Fibromyalgia (FM) tender points: Positive for all the sites (18/18 sites). Muscle pain on grasping with significantly strong muscle tension. Results of tests: No inflammatory findings. Thyroid functions: Normal. Screening for rheumatoid disease: No abnormality. In this case, after the second HPV vaccination, the subject''s painful disorder and sensory disturbance progressed to sleep disorder, followed by respiratory disorder, followed by menstruation abnormal, followed by autonomic dysfunction and then higher cerebral dysfunction, and were becoming multi-layered over time. Accordingly, typical type of HPV vaccination associated with neuropathic syndrome was diagnosed.


VAERS ID: 620358 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-04-16
Onset:0000-00-00
Submitted: 2015-12-29
Entered: 2015-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA123BA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Allodynia, Antinuclear antibody negative, Arthralgia, Atonic seizures, Autonomic nervous system imbalance, Bleeding anovulatory, Blood test normal, Cataplexy, Cognitive disorder, Computerised tomogram head normal, Computerised tomogram normal, Disorientation, Disturbance in attention, Dizziness postural, Double stranded DNA antibody, Dyscalculia, Dyskinesia, Dysmenorrhoea, Dyspnoea, Electroencephalogram normal, Eye pain, Gait disturbance, Gastrointestinal motility disorder, Grip strength decreased, Headache, Hyperacusis, Hyperhidrosis, Hyperventilation, Hypoaesthesia, Hypomenorrhoea, Hypotonia, Initial insomnia, Joint swelling, Loss of personal independence in daily activities, Malaise, Memory impairment, Menstrual disorder, Mental impairment, Middle insomnia, Motion sickness, Myalgia, Narcolepsy, Neurological examination normal, Neuropathy peripheral, Nuclear magnetic resonance imaging normal, Oligomenorrhoea, Pain, Pain in extremity, Photophobia, Post vaccination syndrome, Prosopagnosia, Respiratory disorder, Sensory disturbance, Sleep attacks, Somnolence, Temperature regulation disorder, Thyroid function test normal, Tremor, Wheelchair user
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Parkinson-like events (broad), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific dysfunction (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (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), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Noninfectious diarrhoea (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (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: Allodynia, (+); grasp pain, (+); arthritis/enthesitis, (-); fibromyalgia (FM) point of tenderness, 18/18; Blood tests: Inflammation, (-); thyroid function, (-); antinuclear antibody/anti-double stranded DNA antibody, (-).
CDC Split Type: JP2015JPN169205

Write-up: This case was reported in a literature article and described the occurrence of minimal brain dysfunction in a 19-year-old female subject who received CERVARIX. On 31st July 2010, the subject received the 1st dose of CERVARIX (intramuscular). On 4th September 2010, the 2nd dose was an unknown dose. On 16th April 2011, the 3rd dose was an unknown dose. In May 2013, unknown after receiving CERVARIX, the subject experienced malaise. On an unknown date, the subject experienced minimal brain dysfunction (serious criteria GSK medically significant), cataplexy (serious criteria GSK medically significant), narcolepsy (serious criteria GSK medically significant), post vaccination syndrome, pain in extremity, difficulty in walking, painful arm, knee pain, sweaty hands, car sickness, dizziness on standing up, headache, generalised aching, numbness in hand, tremor, movements involuntary, knee swelling, hyperpnoea, atonic seizures, mental concentration decreased, headache, air hunger, sensory aberrations, temperature regulation disorder, photophobia, eye pain, hyperacusis, trouble falling asleep, nocturnal awakening, daytime sleepiness, sleep attacks, menstruation abnormal, menstrual cycle prolonged, light periods, menses painful, bleeding anovulatory, dyscalculia, cognitive function abnormal, memory impairment, alternation between constipation and diarrhoea, prosopagnosia, spatial disorientation, respiratory disorder, hypotonia, tenderness muscle and autonomic nervous system imbalance. On an unknown date, the outcome of the minimal brain dysfunction, cataplexy, narcolepsy, post vaccination syndrome, pain in extremity, difficulty in walking, painful arm, knee pain, sweaty hands, car sickness, dizziness on standing up, malaise, headache, generalised aching, numbness in hand, tremor, movements involuntary, knee swelling, hyperpnoea, atonic seizures, mental concentration decreased, headache, air hunger, sensory aberrations, temperature regulation disorder, photophobia, eye pain, hyperacusis, trouble falling asleep, nocturnal awakening, daytime sleepiness, sleep attacks, menstruation abnormal, menstrual cycle prolonged, light periods, menses painful, bleeding anovulatory, dyscalculia, cognitive function abnormal, memory impairment, alternation between constipation and diarrhoea, prosopagnosia, spatial disorientation, respiratory disorder, hypotonia, tenderness muscle and autonomic nervous system imbalance were unknown. It was not reported if the reporter considered the minimal brain dysfunction, cataplexy, narcolepsy, post vaccination syndrome, pain in extremity, difficulty in walking, painful arm, knee pain, sweaty hands, car sickness, dizziness on standing up, malaise, headache, generalised aching, numbness in hand, tremor, movements involuntary, knee swelling, hyperpnoea, atonic seizures, mental concentration decreased, headache, air hunger, sensory aberrations, temperature regulation disorder, photophobia, eye pain, hyperacusis, trouble falling asleep, nocturnal awakening, daytime sleepiness, sleep attacks, menstruation abnormal, menstrual cycle prolonged, light periods, menses painful, bleeding anovulatory, dyscalculia, cognitive function abnormal, memory impairment, alternation between constipation and diarrhoea, prosopagnosia, spatial disorientation, respiratory disorder, hypotonia, tenderness muscle and autonomic nervous system imbalance to be related to CERVARIX. The subject had received all the recommended vaccinations, and had never experienced any adverse reactions. About 2 weeks after the third vaccination with HPV vaccine, the subject experienced intense pain in the left arm when playing a violin. Knee pain also developed, which resulted in gait disturbance. The subject left the kendo club as the subject became unable to hold a bamboo sword. The subject started experiencing abnormal malaise, intense hand sweating, car sickness, and dizziness on standing up and started using a wheelchair from August 2012. Examinations including blood tests, electroencephalogram, magnetic resonance imaging (MRI), and computerized tomogram (CT) were performed, but did not reveal any abnormal findings. The subject was told that no diagnosis or treatment can be given. Subsequently, the subject experienced persistent headache, generalized aching, numbness of hands, and tremor-like shaking of fingers starting from the time of awakening, and found it hard to press against the strings of the violin. When intense pain developed, the subject could not do anything but lying down. The subject suffered from hyperpnoea from the feeling as if the subject cannot inhale air. Around September 2013, weakness had progressed, and the subject became unable even to hold a pencil, in addition to a bow of a violin. Although the subject''s concentration had been reduced, the subject was still able to remember musical scores as the subject loved playing a violin. The subject suffered from paroxysmal headache along with the persistent headache, and the subject''s thermaesthesia became obviously different from those of the family members. The subject had poor thermoregulation. The subject occasionally experienced eye pain from progressed sun sensitivity. No hyperacusis or hyperosmia was noted. Sleep disorder (trouble falling asleep, nocturnal awakening) had also progressed, and the subject experienced sudden onset of sleep 2-3 times a day. The subject described school life as a fight against daytime sleepiness. The subject''s condition worsened with stress, low atmospheric pressure, and typhoons. The subject had cyclic menstruation at first, but the interval gradually prolonged with decreased menstrual flow. Menstruation only lasted 2 days. On the first day, the subject experienced intense period pains, and brown-red to black colored blood was noted with coagulated substance. The subject took long to do a simple calculation. The subject used less character and more simplistic form when writing sentences. The subject was able to think logically. However, the subject became terrible with remembering new musical scores. Physical examination: Allodynia, (+); grasp pain, (+); arthritis/enthesitis, (-); fibromyalgia (FM) point of tenderness, 18/18. Blood tests: Inflammation, (-); thyroid function, (-); antinuclear antibody/anti-double stranded DNA antibody, (-). In around May 2013, the subject began to have unusual malaise, headache, general pain, especially in the left side of the body, numbness of the hands and tremor-like trembling of fingers (movements involuntary). The arthralgia was mainly noted in the knee joints, and the left knee was occasionally swollen. In around September 2013, she suddenly collapsed due to weakness (suspected cataplexy). She suddenly fell asleep 2 or three times a day (suspected narcolepsy). Status of attending to school: As of September 2012, when the pain was intense, she was not able to attend school or remained lying down in the classroom, even though she was able to attend school. In September 2013, she was bound to a wheel chair even in the school during her senior year of high school. Her father and mother alternately gave her a ride to school. She was able to attend school every day until mid September, but attended classes with occasional rests by lying down on the bed in the school nurse''s office. She had body pain, even when she was in a seated position. The subject also had intense pain while sitting in a wheel chair. The pain was relieved only when she was lying down. In around March 2014, the subject had intense body pain and felt unwell in her whole body, for which the subject sometimes could attend school only once a week. The pain was persistent. In April 2014, she was enrolled at a university. The body pain was still ongoing, and when she was able to attend classes, she bore the pain. Diagnosis: In this case, after the human papillomavirus (HPV) vaccination, the subject systematically progressed to "pain disorders including pain in extremity and persistent headache", followed by "malaise, numbness and movements involuntary", followed by "respiratory disorders including sensation of dyspnoea", followed by "trouble falling asleep/arousal during sleep", followed by "sleep disorders including daytime sleepiness", followed by "sensory disturbances including photosensitivity", followed by "weakness/cataplexy-like hypotonia/abnormalities in locomotor including muscle pain on grasping", followed by autonomic disorders including lightheadedness and thermoregulatory failure", followed by "menstruation abnormal", and then "mild higher cerebral dysfunction". Moreover, she repeatedly underwent blood tests (for inflammation, collagen disorder and thyroid functions etc.) and head computerised tomogram (CT)/magnetic resonance imaging (MRI) scans, but no abnormalities were identified by current diagnostic methods. Neurological physical examinations also revealed no abnormalities. Based on above mentioned findings, HPV vaccination associated with neuropathic syndrome was diagnosed. Results of relevant tests and procedures associated with the diagnosis: Screening for collagen disorder: Negative.


VAERS ID: 620360 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-08-08
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 AHPVA138AC / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Amnesia, Autonomic nervous system imbalance, Chest pain, Disturbance in attention, Dizziness postural, Dyskinesia, Electrocardiogram normal, Headache, Hyperhidrosis, Hypersomnia, Hyperventilation, Inflammatory marker test, Laboratory test normal, Loss of consciousness, Malaise, Menstruation irregular, Mental impairment, Motion sickness, Pain, Palpitations, Photophobia, Post vaccination syndrome, Respiratory disorder, Thyroid function test normal, Ultrasound chest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dyskinesia (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (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: Physical findings: Fibromyalgia (FM) point of tenderness, (+); intense muscle tightness of the trapezius muscle and overall muscle tenderness, (+); Findings of arthritis: None; Findings of chest and abdomen: None; Findings of blood tests: None; Inflammatory findings: None; Thyroid function: Normal; Screening of collagen disorder: No findings; Electrocardiogram and chest ultrasonography: No abnormality
CDC Split Type: JP2015JPN179664

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of loss of consciousness in a 14-year-old female subject who received CERVARIX (batch number AHPVA100CA, expiry date unknown), (batch number AHPVA122BA, expiry date unknown) and (batch number AHPVA138AC, expiry date unknown). On 7th February 2011, the subject received the 1st dose of CERVARIX (intramuscular). On 7th March 2011, the 2nd dose was an unknown dose. On 8th August 2011, the 3rd dose was an unknown dose. On an unknown date, several months after receiving CERVARIX, the subject experienced loss of consciousness (serious criteria GSK medically significant), minimal brain dysfunction (serious criteria GSK medically significant), pain, hyperpnoea, memory loss transient, chest pain, headache, palpitations, respiratory disorder, malaise, movements involuntary of limbs, sleep excessive, photophobia, irregular menstrual cycle, dizziness on standing up, sweating increased palms, car sickness, mental concentration decreased, autonomic dysfunction and post vaccination syndrome. On an unknown date, the outcome of the loss of consciousness, minimal brain dysfunction, pain, hyperpnoea, memory loss transient, chest pain, headache, palpitations, respiratory disorder, malaise, movements involuntary of limbs, sleep excessive, photophobia, irregular, menstrual cycle, dizziness on standing up, sweating increased palms, car sickness, mental concentration decreased, autonomic dysfunction and post vaccination syndrome were unknown. It was not reported if the reporter considered the loss of consciousness, minimal brain dysfunction, pain, hyperpnoea, memory loss transient, chest pain, headache, palpitations, respiratory disorder, malaise, movements involuntary of limbs, sleep excessive, photophobia, irregular menstrual cycle, dizziness on standing up, sweating increased palms, car sickness, mental concentration decreased, autonomic dysfunction and post vaccination syndrome to be related to CERVARIX. The subject had sometimes placed her head on the desk from 2-3 days after the vaccination. She felt lightning-like pain in the body. At that time, she had hyperpnoea, and was occasionally brought to the dispensary. She had also lost her memories at times. Two months after the HPV vaccination, she visited Hospital, but was told as nothing abnormal. Several days later, she fell due to intense chest pain when dancing, and lost consciousness for 1-2 minutes. Since 2 weeks after the event, she had been transported to a hospital by an ambulance several times due to intense chest pain and loss of consciousness. However, no definitive diagnosis had been made. During this period, examinations including blood tests, chest X-ray photography (XP), electrocardiogram, exercise electrocardiogram, echocardiography, treadmill test, electroencephalogram, and chest magnetic resonance imaging (MRI) were conducted, but no abnormality was pointed out. On 10 January 2012, she visited the department of psychiatry at Medical Center, and she was diagnosed with something psychiatric. Since then, persistent headache on awakening and palpitations had developed. Although the similar symptoms had been persisting, she participated in a short-term study abroad programme in January 2013 as a part of school curriculum. The similar symptoms repeated also in the foreign country. She managed to continue attending school thereafter, but became only able to attend school several days per week. Involuntary movement of upper limbs (she was unable to fill a mark sheet), excessive sleeping, sun sensitivity (she needed a sunglasses), menstrual irregularity (large amount of menstrual flow, dark menstrual flow, involving liver-like clots) developed, in addition to chest pain, respiratory disorder, headache and malaise. As of November 2014, she was unable to attend school except the times for school exams. Recently, dizziness on standing up, sweating of hands, and car sickness had been worsening. Also, her concentration was reduced, and she had to read the same sentences repeatedly so as to understand the contents. This case involved the post-vaccination progression from the initial developed symptoms of intense chest pain, hyperpnoea and losing memories, to pain disorders including generalized aching and chest pain, to malaise, to autonomic nervous system disorders including palpitations, dizziness on standing up and sweating of hands, to menstrual irregularity, to sleep disorder, to sun sensitivity, to movement involuntary, and to mild higher brain dysfunction. In addition, as no abnormality was detected from a series of examinations, human papillomavirus vaccination associated with neuropathic syndrome (HANS) was diagnosed. Physical findings: Fibromyalgia (FM) point of tenderness, (+); intense muscle tightness of the trapezius muscle and overall muscle tenderness, (+). Findings of arthritis: None. Findings of chest and abdomen: None. Findings of blood tests: None. Inflammatory findings: None. Thyroid function: Normal. Screening of collagen disorder: No findings. Electrocardiogram and chest ultrasonography: No abnormality.


VAERS ID: 620361 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-09-13
Onset:2012-05-27
   Days after vaccination:257
Submitted: 2015-12-28
   Days after onset:1310
Entered: 2015-12-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA146AA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Alopecia, Areflexia, Asthenia, Blood test normal, CSF cell count normal, CSF glucose normal, CSF oligoclonal band absent, CSF protein increased, Chills, Computerised tomogram head normal, Deafness unilateral, Decreased appetite, Disturbance in attention, Dizziness postural, Dry skin, Dysarthria, Erythema, Eyelid ptosis, Fasciitis, Fatigue, Feeding disorder, Gait disturbance, Gastrointestinal motility disorder, Grip strength decreased, Guillain-Barre syndrome, Headache, Hyperacusis, Hyperhidrosis, Hypoaesthesia, Hypotension, Immunoglobulin therapy, Initial insomnia, Loss of personal independence in daily activities, Malaise, Memory impairment, Mental impairment, Middle ear effusion, Mobility decreased, Motion sickness, Myalgia, Myringotomy, Nail disorder, Nausea, Nerve conduction studies normal, Nuclear magnetic resonance imaging brain normal, Pain, Palpitations, Post vaccination syndrome, Syncope, Temperature regulation disorder, Thyroid function test normal, Tremor, Vaccination site pain, Vertigo, Weight decreased, Wheelchair user
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal obstruction (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (narrow), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Noninfectious diarrhoea (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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? 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: JP2015JPN179673

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of Guillain-Barre syndrome in a female subject who received CERVARIX (batch number AHPVA123AA, expiry date unknown), (batch number AHPVA123BA, expiry date unknown) and (batch number AHPVA146AA, expiry date unknown). On 7th March 2011, the subject received the 1st dose of CERVARIX (intramuscular). On 11th April 2011, the 2nd dose was an unknown dose. On 13th September 2011, the 3rd dose was an unknown dose. On 27th May 2012, 1 year and 82 days after receiving CERVARIX, the subject experienced pain and shivering. On an unknown date, the subject experienced Guillain-Barre syndrome (serious criteria GSK medically significant), weakness (serious criteria hospitalization), minimal brain dysfunction (serious criteria GSK medically significant), deafness unilateral (serious criteria GSK medically significant), fasciitis, vaccination site pain, erythema, vertigo, feeling queasy, generalised aching, tendon reflex absent, gait disturbance, numbness in hand, numbness in feet, temperature regulation disorder, hyperacusis, malaise, fatigue, trouble falling asleep, headache, inappetence, weight decreased, nail disorder, dry skin, accelerated hair loss, sweating increased palms, alternation between constipation and diarrhoea, dizziness on standing up, palpitations, car sickness, hypotension, syncope, mental concentration decreased, short-term memory impairment, post vaccination syndrome and myalgia. On an unknown date, the outcome of the Guillain-Barre syndrome, minimal brain dysfunction, deafness unilateral, fasciitis, vaccination site pain, feeling queasy, pain, shivering, tendon reflex absent, gait disturbance, numbness in hand, numbness in feet, temperature regulation disorder, hyperacusis, malaise, trouble falling asleep, headache, inappetence, weight decreased, nail disorder, dry skin, accelerated hair loss, sweating increased palms, syncope, mental concentration decreased, post vaccination syndrome and myalgia were unknown and the outcome of the weakness, erythema, vertigo, fatigue, alternation between constipation and diarrhoea, dizziness on standing up, palpitations, car sickness, hypotension and short-term memory impairment were not recovered/not resolved and the outcome of the generalised aching was recovering/resolving. It was not reported if the reporter considered the Guillain-Barre syndrome, weakness, minimal brain dysfunction, deafness unilateral, fasciitis, vaccination site pain, erythema, vertigo, feeling queasy, pain, shivering, generalised aching, tendon reflex absent, gait disturbance, numbness in hand, numbness in feet, temperature regulation disorder, hyperacusis, malaise, fatigue, trouble falling asleep, headache, inappetence, weight decreased, nail disorder, dry skin, accelerated hair loss, sweating increased palms, alternation between constipation and diarrhea, dizziness on standing up, palpitations, car sickness, hypotension, syncope, mental concentration decreased, short-term memory impairment, post vaccination syndrome and myalgia to be related to CERVARIX. After the first CERVARIX vaccination, the subject experienced only localized pain. After the second CERVARIX vaccination, the subject experienced long and thin erythema along the blood vessels in front arms and lower legs without itching. Over the last 4 years, the erythema repeatedly appeared and disappeared (and often developed before a menstrual period). After the third CERVARIX vaccination, the subject experienced severe dizziness and felt queasy. However, she managed to play volleyball as an extracurricular activity. The subject visited an otologist and no abnormalities were detected. On 27 May 2012, the subject experienced pain in her back. Then, chills and shivering developed. The pain spread to the entire body. On 28 May 2012, the subject visited a dermatologist for possible herpes zoster but was notified that herpes zoster lacked evidence. On 31 May 2012, as the pain in her back persisted, the subject was referred to Hospital A. She was hospitalized for deteriorating weakness. On 01-02 June 2012, the pain in her back deteriorated and tendon reflex was absent. The weakness progressed and the subject was not able to hold chopsticks or walk and required a wheelchair. The weakness was more severe at the left side vaccinated three times. At that time, the weakness occurred not only in the extremities but in her whole body, with symptoms including eyelid ptosis, inarticulateness and inability to turn over in bed. She developed numbness at fingers and feet and was not able to sweat or control the body temperature. Cerebrospinal fluid tests showed somewhat high protein levels leading to a diagnosis of Guillain-Barre syndrome. On the other hand, blood tests, the nerve conduction velocity and brain computerized tomogram (CT)/magnetic resonance imaging (MRI) showed normal results. The subject received massive gamma-globulin therapy. It was effective and the numbness, eyelid ptosis and inability to hold chopsticks resolved with present tendon reflex. As deafness left ear developed, the subject visited an otologist at the same time. Fluid was accumulated in the ear and temporarily improved by myringotomy but the event repeated thereafter. The subject was treated with tubing for a while. The subject got sensitive to sound and repeated shakiness when hearing buzzing of cicadas or screech of brakes of motor trucks. One month after the admission, the subject used a walker instead of a wheelchair and was transferred to Rehabilitation Center B. One year after the transfer to Rehabilitation Center B, severe malaise and fatigability started. Sleep disorder (trouble falling asleep), headache, feeling queasy and generalized pain were added and she was not able to eat, resulting in weight loss by 10 kg. Undulated nails, dried skin and hair loss were observed. The subject was not able to control the body temperature and sweated much at hands with soaked papers in her hands. However, she had a regular menstrual period. The subject was admitted to Center C and received steroid pulse therapy without effectiveness. The subject received massive gamma-globulin therapy again and only generalized pain improved. At the time of reporting, when she walked for long (around 30 minutes), she suffered from severe fatigability and required a wheelchair. Her muscles of the arm repeatedly gained and lost power and also repeated constipation and diarrhoea. She always experienced dizziness on standing up, palpitations, dizziness and car sickness. She Hypotension and her systolic pressure often showed 75-80 mmHg. Galactorrhoea was never observed. She experienced syncope only once. The symptoms deteriorated at rainy weather, low atmospheric pressure such as typhoon, tension or psychological stress or before menstrual periods. Her concentration was decreased. Calculation, writing and reading were fine but she developed short-term memory impairment. Physiological findings: Tendon reflex: normal, Tender point: 18/18 positive, Muscle pain on grasping (allodynia); positive, No articular findings, No higher brain dysfunction. Hematological findings: Inflammatory findings: None, Thyroid function: normal, Screening for collagen disorder: no abnormalities. Brain CT/MRI: no abnormalities. Nerve conduction velocity: no abnormalities. Cerebrospinal fluid protein: 48 mg/dL, Cerebrospinal fluid sugar: 56 mg/dL, Cerebrospinal fluid cell count: 1/mm3, Cerebrospinal fluid (CSF) oligoclonal band: negative. Attending school: Though the subject repeatedly visited medical institutions as an outpatient and was often hospitalized, she managed to attend school. Her mother gave her a ride to and from school every day. She attended school about 2 hours for 6-hour lessons and had to spend other hours at rest at the nurse''s office. As she did not sweat or control the body temperature, she did not join gym classes. In this case, pain disorders including generalized pain, pain in the back and persistent headache developed at first and subsequently progressed to allergic symptoms including erythema and rash pruritic, next autonomic nervous system disorders including dizziness, feeling queasy, severe weakness, absent tendon reflux, numbness at fingers, inability to control the body temperature, dizziness on standing up and repeated constipation and diarrhoea, next sensory aberrations including sound sensitivity increased, next severe malaise, fatigability and sleep disorder (mainly trouble falling asleep) and finally mild higher brain dysfunction. On the other hand, contemporary testing techniques including various blood tests, brain CT/MRI and nerve conduction velocity did not detect any abnormalities and HPV vaccination associated with neuropathic syndrome was diagnosed. The medical institute diagnosing Guillain-Barre syndrome reported cerebrospinal fluid protein level at 48 mg/dL, cerebrospinal fluid sugar level at 56 mg/dL, cerebrospinal fluid cell count: 1/mm3 and negative CSF oligoclonal band. No albuminocytologic dissociation was observed and typical Guillain-Barre syndrome was not identified.


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