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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: 620415 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-12-03
Onset:0000-00-00
Submitted: 2015-12-29
Entered: 2015-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 9QN03R / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Amnesia, Antinuclear antibody, Antinuclear antibody negative, Arthralgia, Asthenia, Blood test normal, CSF test normal, Cataplexy, Constipation, Diarrhoea, Disturbance in attention, Dizziness postural, Double stranded DNA antibody, Fatigue, Feeling abnormal, Fibromyalgia, Gait disturbance, Headache, Hot flush, Hyperhidrosis, Hypersomnia, Inflammatory marker test, Influenza virus test negative, Insomnia, Listless, Malaise, Memory impairment, Mental impairment, Myalgia, Neuropathy peripheral, Nuclear magnetic resonance imaging brain normal, Poor quality sleep, Pyrexia, Syncope, Temperature regulation disorder, Thyroid function test normal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Pseudomembranous colitis (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), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), 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? 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: Infantile asthma; Dermatitis atopic; Food allergy, around two years old; Food allergy, around two years old; Milk allergy, around two years old
Allergies:
Diagnostic Lab Data: On unspecified date, blood test findings: no inflammatory findings; no abnormality in thyroid function; negative result in screening for collagen disorder; antinuclear antibody negative (-); anti-dsDNA antibody negative (-); anti-SS-A antibody negative (-); anti-RNP antibody negative (-). On unspecified date, head MRI: No abnormality found. Influenza test was performed at a nearby hospital, but the result was negative, detailed examinations (blood test, cerebrospinal fluid test and imaging tests) were performed at Hospital M, which all showed no abnormality. She had hot flashes/flushes and her temperature regulation was abnormal.
CDC Split Type: WAES1512JPN013179

Write-up: Initial information has been received from a physician via the Agency (agency # V15101005) concerning a 15 year old female patient with food allergy (milk, egg albumen and chicken) and medical history of atopic dermatitis and infantile asthma who on 03-DEC-2011 was intramuscularly vaccinated with GARDASIL (Lot no. reported as 9QN01R, dose not reported). Special notes on the pre-vaccination interview form (including underlying disease, allergy, vaccination/disease within the last 1 month, medications currently taken, adverse reaction history and growth status) were not reported. Other concomitant medications were not reported. Before the vaccination of human papillomavirus VLP (HPV) vaccine -Club activity: The patient had been actively participating in the swimming club and flower arrangement club. In addition, she had been going to a dance class and had been physically active with self-confidence in her physical strength. She had perfect attendance during junior high school. Her school grades were excellent (she was going to a high-level high school). -Medical history: Food allergy (milk, egg albumen and chicken) at around the age of 2, atopic dermatitis, infantile asthma. Vaccination with GARDASIL. On 01-OCT-2011 (also reported as on 01-OCT-2012), the patient received GARDASIL for the first time (Lot no. reported as 9QN01R). On 03-DEC-2011, the patient received GARDASIL for the second time (Lot no. reported as 9QN01R). On 21-APR-2012, the patient received GARDASIL for the third time (Lot no. 9QN03R). Medical facility where the patient received the vaccinations: Pediatrics department in City Y.


VAERS ID: 620417 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-03-31
Onset:0000-00-00
Submitted: 2015-12-30
Entered: 2015-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0277AA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abulia, Apathy, Arthralgia, Asthenia, Atonic seizures, Autonomic nervous system imbalance, Blood test normal, Cataplexy, Constipation, Decreased appetite, Dementia, Depression, Dermatitis atopic, Diarrhoea, Disturbance in attention, Dizziness, Dizziness postural, Dysmenorrhoea, Electroencephalogram normal, Fall, Fatigue, Fibromyalgia, Gait disturbance, General physical condition abnormal, Headache, Hypersomnia, Loss of personal independence in daily activities, Lymph node pain, Lymphadenopathy, Malaise, Memory impairment, Menstrual disorder, Mental impairment, Mobility decreased, Muscular weakness, Myalgia, Narcolepsy, Neuropathy peripheral, Nuclear magnetic resonance imaging brain normal, Pain, Palpitations, Reading disorder, Scan, Sensitivity to weather change, Single photon emission computerised tomogram normal, Sleep disorder, Somnolence, Speech disorder, Tenderness, Thyroid function test normal, X-ray normal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (narrow), Convulsions (narrow), Pseudomembranous colitis (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (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) (narrow), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), 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? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Seasonal allergy
Preexisting Conditions: Seasonal allergy
Allergies:
Diagnostic Lab Data: physical examination findings included fibromyalgia with points of tenderness (+); no allopdynia; enlargement of cervical lymph nodes with tenderness. On unspecified date, blood test. head magnetic resonance imaging (MRI) and single photon emission computerised tomogram (SPECT) were performed. no abnormality was pointed out. From September to November 2013. X-rays scans and blood tests were performed but collagen disorder and rheumatism were ruled out. The cause was unknown. On unspecified date. no inflammation on blood test; no abnormality in thyroid functions; negative result in screening for collagen disorder; no abnormal wave on electroencephalogram; no abnormality on repeated head MRI; no abnormality on repeated SPECT; Blood test, no inflammation; Blood test, no abnormality was pointed out; 2013, Blood test, collagen disorder and rheumatism were ruled out; Electroencephalogram, no normal wave; Investigation, negative result; Nuclear magnetic resonance imaging brain, no abnormality was pointed out; Nuclear magnetic resonance imaging brain, no abnormality; Single photon emission computerised tomogram, no abnormality; Single photon emission computerised tomogram, no abnormality was pointed out; Thyroid function test, no abnormality not provided; 2013, X-ray, collagen disorder and rheumatism were ruled out
CDC Split Type: WAES1512JPN013140

Write-up: This spontaneous report as received from a physician via the Agency (HA#V15100997), concerning a 14 year old female patient with medical history of pollinosis who on 31-MAR-2012 was intramuscularly vaccinated with GARDASIL injection (Lot no. 9QN03R, vaccination dose not reported). Special notes on the pre-vaccination interview form (including underlying disease, allergy, vaccination/ disease within the last 1 month, medications currently taken, and adverse reaction history and growth status) were not reported. Other concomitant medications were not reported. Before the vaccination of GARDASIL: History of adverse reactions to vaccination: None Medical history: Pollinosis School grades: She had good grades. She had been actively participating in club activity of a drama club after entering a junior high school, but had not been doing exercises in particular. On 27-SEP-2011, the patient received GARDASIL for the first time (Lot no. 9QN02R). On 27-NOV-2011, the patient received GARDASIL for the second time (Lot no. 9QN02R). On 31-MAR-2012, the patient received GARDASIL for the third time (Lot no. 9QN03R). Chief complaints at consultation with staff of City Y: In April 2013 Malaise of the body, unable to wake up in the morning, lack of energy in June 2014 (at the first consultation) Sudden weakness on walking, weakness, unable to read books since she could not understand the written letters, dizziness on standing up, dizziness, in appetence (as of June 2014, her height was 160 cm and body weight was around 40Kg), unstable neck (occasional, recover after leaning her against the wall for a while), headache No numbness and palpitations. Hospital visits for the post-vaccination symptoms: The patient visited clinics (3 hospitals) from September to November 2013. X-ray scans and blood tests were performed but collagen disorder and rheumatism were ruled out. The cause was unknown. Hospital Y: Hospitalized for a week during from September to November 2013 due to worsening of atopic dermatitis. Clinical course after vaccination with HPV vaccine: After the vaccination with HPV vaccine in March 2013, the patient experienced symptoms including abnormal malaise of the body, loss of motivation (lack of energy) (abulia) and difficulty in waking up in April 2013. She felt poor physical condition and visited a school counselor by herself. The patient was recommended to visit the department of medicine and was diagnosed as "mild depression". Oral medicine was prescribed but had no effect. The symptoms persisted thereafter, and she also frequently had sudden weakness in the knees on walking and collapsed. In addition, the patient repeatedly could not put strength in the whole body (weakness) and had unstable neck (the unstable neck recovered after leaning her against the wall for a while). Dizziness on standing up, dizziness and headache became severe and her appetite decreased. The patient had severe tiredness and could not speak when she was tired, so she started to communicate with gestures. She became unable to understand the content of the book which she was reading. She quitted the drama club since she could not memorize the script. She was in the first grade of a high school, but hardly could go to school. Although blood test, head magnetic resonance imaging (MRI) and single photon emission computerized tomogram (SPECT) were performed, no abnormality was pointed out. On 03-JUL-2014, the patient visited the reporting hospital for the first time. She visited the hospital with chief complaint of various symptoms including general malaise, dizziness (like severe car sickness), difficulty in waking up, sleepiness in daytime, weakness, palpitations, memory impairment, immediate loss of concentration, hyperpnoea, difficulty in understanding the contents of books, sound sensitivity, repeated diarrhoea and constipation, abnormal menstruation: severe period pains (unable to get out of the bed), very dark menstrual blood. On 11-SEP-2014, memantine hydrochloride was prescribed. On an unspecified date, the frequency of arthralgia decreased after the start of memantine hydrochloride but the joints and muscles were still stiff and swollen. The patient occasionally had headache as well as dull headache. Weakness (suspected cataplexy) was noted and the patient went to sleep even during the daytime due to severe sleepiness (excess sleeping, suspected narcolepsy). She had no dysgraphia and could calculate but required some time. She still could not understand the contents of books despite reading the letters. In addition, dizziness on standing up, dizziness, palpitations, repeated diarrhoea and constipation persisted, while loss of motivation became severe (suspected dementia). In times of atmospheric depression, rain, the patient''s physical condition worsened. Findings of physical examination included: fibromyalgia with points of tenderness (+); no allopdynia; enlargement of cervical lymph nodes with tenderness; no inflammation on blood test; no abnormality in thyroid function; negative result in screening for collagen disorder; no abnormal wave on electroencephalogram; no abnormality on repeated head MRI; no abnormality on repeated SPECT. School attendance: She was in the first grade of a high school, but hardly could go to school. Diagnosis: According to the aforementioned clinical course and information, the patient presented with abnormal malaise after the vaccination with HPV vaccine (vaccination complication), followed by loss of abulia. Thereafter, her disease condition progressed as in the following order: pain disorders (headache, myalgia, arthralgia), atonic seizures and muscle weakness, autonomic dysfunction (dizziness on standing up, dizziness, headache, palpitations, repeated diarrhoea and constipation), abnormal menstruation, sleep disorder (excess sleeping), higher brain dysfunction (loss of motivation, decreased concentration, lack of sentence understanding). Eventually, the patient was diagnosed as "HPV associated neuropathic syndrome". As of the time of reporting on 21-DEC-2015, the outcomes of worsening of atopic dermatitis, abnormal malaise, loss of motivation, pain disorders (headache, myalgia, arthralgia), atonic seizures, muscle weakness, autonomic dysfunction (dizziness on standing up, dizziness, headache, palpitations, repeated diarrhoea and constipation), abnormal menstruation, sleep disorder (excess sleeping), higher brain dysfunction (loss of motivation, decreased concentration, lack of sentence understanding) and HPV associated neuropathic syndrome were unknown. Reporter''s comment: Not provided The reporting physician considered that worsening of atopic dermatitis was serious due to hospitalization. The reporting physician did not assess the seriousness of abnormal malaise, loss of motivation, pain disorders (headache, myalgia, arthralgia), atonic seizures, muscle weakness, autonomic dysfunction (dizziness on standing up, dizziness, headache, palpitations, repeated diarrhoea and constipation), abnormal menstruation, sleep disorder (excess sleeping), higher brain dysfunction (lack of motivation, decreased concentration, lack of sentence understanding) and HPV associated neuropathic syndrome. The reporting physician did not assess the causal relationship of atopic dermatitis, abnormal malaise, loss of motivation, pain disorders (headache, myalgia, arthralgia), atonic seizures, muscle weakness, autonomic dysfunction (dizziness on standing up, dizziness, headache, palpitations, repeated diarrhoea and constipation), abnormal menstruation, sleep disorder (excess sleeping), higher brain dysfunction (loss of motivation, decreased concentration, lack of sentence understanding) and HPV associated neuropathic syndrome to GARDASIL. Additional information is not expected since it is an Agency report.


VAERS ID: 620517 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-07-04
Onset:0000-00-00
Submitted: 2015-12-30
Entered: 2015-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA162AA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Asthenia, Autonomic nervous system imbalance, Blood test normal, Cognitive disorder, Dizziness postural, Dyscalculia, Dysmenorrhoea, Faeces soft, Fibromyalgia, Gait disturbance, Hyperacusis, Hyperhidrosis, Hyperkinesia, Hyperventilation, Initial insomnia, Malaise, Memory impairment, Menstrual discomfort, Menstruation irregular, Mental impairment, Middle insomnia, Muscle tightness, Pain, Parosmia, Photophobia, Post vaccination syndrome, Pyrexia, Restless legs syndrome, Sensory disturbance, Temperature regulation disorder, Tendon disorder, Tremor
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (narrow), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dystonia (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), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Fertility disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SOLONAX; DEPAS
Current Illness: 06/2012, Rhinitis allergic; Headache
Preexisting Conditions: Urticaria; Injury; Urticaria
Allergies:
Diagnostic Lab Data: Blood tests: No abnormally observed; Physical findings: Tender points: 18/18 (positive), Muscle tension: Present at the thighs and brachial muscles, Tenderness: Present at periarticular muscles/tendons
CDC Split Type: JP2015JPN182164

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 AHPVA162AA, expiry date unknown). The subject''s past medical history included injury. Previously experienced adverse reactions included pharmacological urticaria. Concurrent medical conditions included rhinitis allergic, headache and allergic urticaria. Concomitant products included DEPAS and SOLANAX. On 1st December 2011, the subject received the 1st dose of CERVARIX (intramuscular). On 4th January 2012, the 2nd dose was an unknown dose. On 4th July 2012, the 3rd dose was an unknown dose. In February 2012, less than a year after receiving CERVARIX, the subject experienced generalised aching. In March 2012, the subject experienced fibromyalgia syndrome. On an unknown date, the subject experienced post vaccination syndrome (serious criteria disability), mental impairment (serious criteria GSK medically significant), arthralgia, slight fever, malaise, hyperpnoea, irregular menstrual cycle, menses painful, menstrual discomfort, cognitive function abnormal, photophobia, hyperacusis, altered smell sensation, difficulty in walking, trouble falling asleep, nocturnal awakening, weakness, shaking of hands, memory impairment, dyscalculia, restless legs syndrome, hyperkinesis, dizziness on standing up, temperature regulation disorder, sweating abnormal, sweating increased palms, faeces soft, autonomic dysfunction, muscle tightness, tendon disorder and sensory aberrations. The subject was treated with theophylline, MEMARY and ROZEREM. On an unknown date, the outcome of the post vaccination syndrome, mental impairment, fibromyalgia syndrome, generalised aching, arthralgia, slight fever, malaise, hyperpnoea, irregular menstrual cycle, menses painful, menstrual discomfort, cognitive function abnormal, hyperacusis, altered smell sensation, difficulty in walking, trouble falling asleep, nocturnal awakening, weakness, shaking of hands, memory impairment, dyscalculia, restless legs syndrome, hyperkinesis, dizziness on standing up , temperature regulation disorder, sweating abnormal, sweating increased palms, faeces soft, autonomic dysfunction, muscle tightness, tendon disorder and sensory aberrations were not recovered/not resolved and the outcome of the photophobia was unknown. It was not reported if the reporter considered the post vaccination syndrome, mental impairment, fibromyalgia syndrome, generalised aching, arthralgia, slight fever, malaise, hyperpnoea, irregular menstrual cycle, menses painful, menstrual discomfort, cognitive functions abnormal, photophobia, hyperacusis, altered smell sensation, difficulty in walking, trouble falling asleep, nocturnal awakening, weakness, shaking of hands, memory impairment, dyscalculia, restless legs syndrome, hyperkinesis, dizziness on standing up, temperature regulation disorder, sweating abnormal, sweating increased palms, faeces soft, autonomic dysfunction, muscle tightness, tendon disorder and sensory aberrations to be related to CERVARIX. Before the vaccination: When the subject was in the final year of elementary school, the subject occasionally complained of headache. when the subject was in the first year of middle school, the subject fell off a bike and had major injury. Headache worsened from the second semester, and the subject attended school only 1-2 times a month. The subject visited the psychosomatic medicine department, and was prescribed DEPAS and SOLANAX. After the subject advanced to the second year of middle school, the subject became able to attend to the school dispensary. On an unknown date, menstrual cycle was irregular, and period pains were intense (the subject had had period pains since before, but the intensity became more severe, and the subject was unable to keep a standing position and also had queasy feeling). Recently, when reading books, the subject was just following the letters, and could not understand the contents. The subject felt dazzled by lights (sunlight or bright fluorescent lights) (photosensitivity). Hyperosmia was noted (such as Air refresher in a car). The subject experienced transient gait disturbance, sleep disorder (trouble falling asleep and interrupted sleep), weakness, tremor-like shaking of hands, and memory impairment. The subject became unable to do simple calculations. The subject felt restless in legs, and something thick was flowing through the body (possible restless legs syndrome). The subject cannot stop herself from moving her body all the time. The subject also experienced dizziness on standing up, temperature regulation disorder, abnormal sweating (the subject sweated when others were feeling cold)/sweating of hands, and persistent soft stool (autonomic dysfunction). The subject was referred to the reporting department by a local physician for suspected juvenile fibromyalgia syndrome. On 25 April 2012, the subject visited the reporting department for the first time with complaints of generalized aching (felt like being pricked from inside the body), arthralgia (migratory), slight fever, persistent abnormal listlessness, malaise, and occasional hyperpnoea. Theophylline, memantine, and ROZEREM were prescribed, and were confirmed to be effective. It was reported that the symptoms would show an improving tendency in about half a year. As the symptoms including photosensitivity, generalized aching, listlessness, and mental concentration worsened when MEMARY was temporarily discontinued. MEMARY was resumed. ROZEREM was effective at a half dose. The subject was being seen in cooperation with other medical institutions. As of 07 December 2015, the outcome of the symptoms was unresolved. Results of relevant tests and procedures associated with the diagnosis: Blood tests: No abnormality observed. Physical findings: Tender points: 18/18 (positive). Muscle tension: Present at the thighs and brachial muscles. Tenderness: Present at periarticular muscles/tendons. Status of school attendance: The subject could not advance to the next year due to insufficient attendance, and was thus transferred to a correspondence high school. The subject visited the hospital for screening 1-2 times a month. This subject was referred to the reporting department for juvenile fibromyalgia syndrome, based on the family/school circumstances, character tendency, and the situation in the upper years of elementary school. However, the medical interview revealed that, after the CERVARIX vaccination, the subject experienced multi-layering of symptoms including pain disorders, followed by menstruation abnormal, followed by abnormal listlessness/malaise, followed by autonomic dysfunction, followed by sensory disturbance, and followed by higher brain dysfunction such as memory impairment/cognitive disorder. Accordingly, human papillomavirus (HPV) vaccination associated with neuropathic syndrome was diagnosed.


VAERS ID: 621009 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-03-10
Onset:0000-00-00
Submitted: 2016-01-21
Entered: 2016-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Agnosia, Amenorrhoea, Autonomic nervous system imbalance, Blood test normal, Complex regional pain syndrome, Computerised tomogram normal, Constipation, Diarrhoea, Dizziness postural, Dyspnoea, Headache, Hyperacusis, Hypomenorrhoea, Malaise, Memory impairment, Menorrhagia, Mental impairment, Motion sickness, Neuropathy peripheral, Nuclear magnetic resonance imaging normal, Pain in extremity, Palpitations, Photophobia, Post vaccination syndrome, Postural orthostatic tachycardia syndrome, Sensory disturbance, Somatic symptom disorder, Tenderness
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Fertility disorders (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (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:
CDC Split Type: JP2016JPN005152

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of post vaccination syndrome in a adolescent female subject who received CERVARIX (batch number AHPVA097AA, expiry date unknown), (batch number AHPVA097BA, expiry date unknown) and (batch number AHPVA123AA, expiry date unknown). On 9th September 2010, the subject received the 1st dose of CERVARIX (intramuscular). On 12th October 2010, the 2nd dose was an unknown dose. On 10th March 2011, the 3rd dose was unknown dose. On an unknown date, unknown after receiving CERVARIX, the subject experienced post vaccination syndrome (serious criteria clinically significant/intervention required), cerebration impaired (serious criteria GSK medically significant), painful arm, absence of menstruation, menorrhagia, hypomenorrhoea, headache, pain in extremity, somatoform disorder, autonomic dysfunction, malaise, dizziness on standing up, car sickness, palpitations, dyspnoea, diarrhoea, constipation, sensory aberrations, photophobia, sound sensitivity increased, memory impairment, agnosia and tenderness. On an unknown date, the outcome of the post vaccination syndrome was not recovered/not resolved and the outcome of the cerebration impaired, painful arm, absence of menstruation, menorrhagia, hypomenorrhoea, headache, pain in extremity, somatoform disorder, autonomic dysfunction , malaise, dizziness on standing up, car sick ness, palpitations, dyspnoea, diarrhoea, constipation, sensory aberrations, photophobia, sound sensitivity increased, memory impairment, agnosia and tenderness were unknown. The reporter considered the post vaccination syndrome to be related to CERVARIX. It was not reported if the reporter consider the cerebration impaired, painful arm, absence of menstruation, menorrhagia, hypomenorrhoea, headache, pain in extremity, somatoform disorder, autonomic dysfunction, malaise, dizziness on standing up, car sickness, palpitations, dyspnoea, diarrhoea, constipation, sensory aberrations, photophobia, sound sensitivity increased, memory impairment, agnosia and tenderness to be related to CERVARIX. On an unknown date, the subject had intense painful arms just after the vaccination. Her menstrual periods stopped half a year after the vaccination, and she visited the department of obstetrics and gynecology, where she was told to have nothing abnormal. Regarding her periods, menstruation abnormal persisted thereafter in such a way it involved transition from menorrhagia to hypomenorrhoea. Subsequently, pain disorder mainly including headache and pain in extremity had progressed to autonomic dysfunction including abnormal listlessness, dizziness on standing up, car sickness, palpitations, dyspnoea, and repeated diarrhoea and constipation, followed by sensory disturbance including photophobia and sound sensitivity increased, and then higher cerebral dysfunctions including memory impairment and agnosia. The symptoms were complicated and had been increasingly multi-layered. No abnormality was noted in blood tests, head computerized tomogram (CT), and magnetic resonance imaging (MRI). However, from the physical point of view, marked tenderness was noted at the tendon attachment. HPV vaccination associated with neuropathic syndrome was diagnosed. Results of relevant tests and procedures associated with the diagnosis: Blood tests: No abnormality Head computerized tomogram (CT): No abnormality magnetic resonance imaging (MRI): No abnormality The diagnosis was not simply complex regional pain syndrome (CRPS) or postural tachycardia syndrome (POTS), but was confirmed as HPV vaccination with neuropathic syndrome, which includes CRPS and POTS, but was confirmed as HPV vaccination associated with neuropathic syndrome, which includes CRPS and POTS as well as leads to higher cerebral dysfunctions. Other possible etiological factor: None


VAERS ID: 629849 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-01
Entered: 2016-03-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cognitive disorder, Dyskinesia, Gait disturbance, Hypoaesthesia, Malaise, Mental impairment, Pain, Sensory disturbance, Sleep disorder, Visual impairment
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: JP2016JPN027183

Write-up: This case was reported by a regulatory authority via regulatory authority and described the occurrence of pain in a 15-year-old female subject who received CERVARIX. In September 2011, the subject received CERVARIX (intramuscular). In October 2011, the dose was an unknown dose. On an unknown date, unknown after receiving CERVARIX, the subject experienced pain (serious criteria clinically significant/intervention required), movements involuntary (serious criteria clinically significant/intervention required), numbness (serious criteria clinically significant/intervention required), cognitive disorder (serious criteria clinically significant/intervention required), malaise (serious criteria clinically significant/intervention required), visual impairment (serious criteria clinically significant/intervention required), sleep disorder (serious criteria clinically significant/intervention required), sensory aberrations (serious criteria clinically significant/intervention required), gait disturbance (serious criteria clinically significant/intervention required) and cerebration impaired (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the pain, movements involuntary, numbness, cognitive disorder, malaise, visual impairment, sleep disorder, sensory aberrations, gait disturbance and cerebration impaired to be related to CERVARIX.


VAERS ID: 634105 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-10-30
Onset:2012-10-30
   Days after vaccination:0
Submitted: 2016-04-05
   Days after onset:1253
Entered: 2016-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0700AA / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Activities of daily living impaired, Arthralgia, Asthenia, Autonomic nervous system imbalance, Disturbance in attention, Dizziness, Dizziness postural, Dysmenorrhoea, Fall, Feeling abnormal, Fibromyalgia, Gait disturbance, Headache, Hyperhidrosis, Hypersomnia, Hyperventilation, Hypoaesthesia, Inflammatory marker decreased, Initial insomnia, Insomnia, Irritability, Laboratory test normal, Limb injury, Malaise, Menorrhagia, Menstrual disorder, Menstruation irregular, Mental impairment, Mobility decreased, Mood swings, Motor dysfunction, Muscle spasms, Muscular weakness, Myalgia, Neurological examination normal, Neuropathy peripheral, Nuclear magnetic resonance imaging normal, Pain, Palpitations, Photophobia, Rash, Rash erythematous, Single photon emission computerised tomogram normal, Sleep disorder, Thyroid function test normal, Tinnitus, Walking aid user, X-ray normal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Hostility/aggression (broad), 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), Hypersensitivity (narrow), Arthritis (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: In January 2014, the patient underwent neurological examinations including a single-photon emission computerized tomography (SPECT) at the neurology department of Hospital but no abnormality was found. Physical examination: Fibromyalgia (FM) tender point (++); muscle pain on grabbing (+); no finding of arthritis; no chest/abdominal findings; blood test: inflammation (-); thyroid function: normal; screening for collagen diseases (-). An orthopedic hospital in city: No abnormality was found on X-ray and magnetic resonance imaging (MRI).
CDC Split Type: WAES1512JPN014223

Write-up: This spontaneous report has been received from regulatory authority referring to a 12 year old female patient. The patient''s historical conditions, concurrent conditions and concomitant medications were not reported. On 04-JUL-2012, 30-OCT-2012 and 25-MAR-2013, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) injection, intramuscular (dose unspecified). On an unknown date the patient experienced numbness, malaise, neuropathy, cerebration impaired, mental concentration decreased, autonomic dysfunction, sweating increased palms, dizziness, dizziness on standing up, menstruation abnormal, motor dysfunction, weakness, difficulty in walking, sleep disorder and pain. The outcome of numbness, malaise, neuropathy, cerebration impaired, mental concentration decreased, autonomic dysfunction, sweating increased palms, dizziness, dizziness on standing up, menstruation abnormal, motor dysfunction, weakness, difficulty in walking, sleep disorder and pain was reported as unknown. The reporter considered numbness, malaise, neuropathy, cerebration impaired, mental concentration decreased, autonomic dysfunction, sweating increased palms, dizziness, dizziness on standing up, menstruation abnormal, motor dysfunction, weakness, difficulty in walking, sleep disorder and pain to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown). Follow-up information has been received from a physician and also from the Agency. Information including the underlying/concomitant diseases and medical history was not obtained. No specific notes were reported in the medical interview sheet (underlying disease, allergy, vaccination and diseases within the last 1 month, drugs currently taken, history of adverse reaction, growth status, etc.). No other concomitant drug was reported. Before the vaccination of HPV vaccine - The patient was the president of the club. Academic grade: Fair. Details of the vaccination with HPV vaccine: Vaccination date: On 04-JUL-2012, 30-OCT-2012, 25-MAR-2013, the patient received the first, the second and the third dose of GARDASIL (first dose: batch # 9QN04R, lot # 0308AA with unknown expiration date; second dose: batch # 9QN06R, lot # 0700AA with expiration date 01-JUN-2014; third dose: batch # 9QN08R, lot # 0989AA with expiration date 21-JUN-2014, dose not reported) intramuscularly. Hospital where the patient received the vaccinations. Chief complaints at consultation with staff: Numbness in the tip of the first digit (left foot), prick pain, occasional inability to walk; weakness (weakness of the knees); dull headache; strange sensation of the peri scapular region; giddiness (occasional); hand symptoms (-); palpitation (-). Hospital visits for the post-vaccination symptoms: A local orthopedic hospital: The cause could not be specified. An orthopedic hospital in city: No abnormality was found on X-ray and magnetic resonance imaging (MRI). Hospital (pediatric department). Clinical course after vaccination with HPV vaccine: On 30-OCT-2012, the patient developed pain disorder (including headache and body pain), numbness and HPV associated neuropathic syndrome. On an unspecified date, after the second dose of the vaccine, the patient noticed numbness of left toes and prick pain, and became difficult to walk. The patient visited a local orthopedic hospital but the cause was unknown. From around winter of 2013, as the patient had occasional headache and dull headache, she treated herself with over-the-counter drugs (OTCs). She often felt low and mood swings became more pronounced. The patient developed malaise at an abnormal frequency and became unable to sleep in the night. From around May in 2014, the patient had weakness of the knees and often fell down. The patient also often fell over on the way to school and thus felt fear for her physical safety with worrying about falling down on the roadway. She often experienced sudden weakness, followed by pain in the hips with generalized pain, particularly in bad weather. The patient was able to attend classes but often fell forward due to a sudden weakness of the knees during the 20 minute-walk to school. She often fell over in the campus. From October 2013, the patient started using a cane on a daily basis. In December 2013, the patient developed dizziness on standing up. On 25-DEC-2013, the patient made an initial visit to the reporting department. The patient used a cane for walking. The patient had persistent pain from the left upper body to the scapula and became unable to raise her arm. The patient attended classes but observed the gymnastic class because of frequent falling. The patient was unable to walk on the slope without using a handrail. The patient had been using a cane since October 2013. The patient had no hypersensitivities to light and sound but had persistent tinnitus. Dizziness on standing up and giddiness as well as severe palm sweating were noted. Menstruation started at the fourth grade but the cycle was irregular. No amenorrhoea was noted. Recently, however, the patient was concerned about black menstrual blood seen in the latter half of the menstrual cycle. Period pains became severe. The patient experienced mental concentration decreased and a marked mood swings and got easily irritated. No calculating ability decreased was noted. She initially suffered from sleeplessness but recently rather from abnormally long sleep duration. In January 2014, the patient underwent neurological examinations including a single-photon emission computerized tomography (SPECT) at the neurology department of a hospital but no abnormality was found. Red raised rash started to appear on the face and thighs. The patient was prescribed with MEMARY and THEODUR at the outpatient department and pain disorder considerably improved with the drugs but on the contrary the patient seemed to become psychologically unstable. At night, trouble falling asleep recurred and thus the patient started to use ROZEREM. In March, the patient passed the university entrance examination. She felt relief from the stress of the entrance test. The patient sometimes collapsed to her knees due to weakness. The patient could not get up in the morning of the following day of rehabilitation due to malaise. Recently, the patient started to have a large amount of menstrual blood with intensified period pain. Dark clotting blood was noted during each menstrual cycle. Headache considerably improved with oral MEMARY and THEODUR but dull headache remained persistent. She often had palpitations and felt uneasy with palm sweating. Hyperpnea occurred due to insufficient breathing. She felt muscle cramp in the face. The patient fell down due to giddiness and was sent to the sick room in a stretcher. In September 2014, the general condition became favorable and the patient started to resume walking without using a wheelchair. Headache started in the early morning and persisted all day long with occasional headache attack with a spasm of body collapsing. The patient was repeatedly sent to the sick room because of deterioration of giddiness. The patient felt hypersensitivity to the sunlight and fluorescent but not to sounds. The patient was able to do simple calculation and write characters. The patient could read the books necessary for classes. However her mental concentration steadily decreased and she was worried about no progress in her study. The patient was prescribed with multiple herbal medicines at hospital but could not take all the drugs due to excessive quantities of the prescription. Her physical condition became worse in menstrual periods and when typhoon was approaching. Physical examination: Fibromyalgia (FM) tender point (++), muscle pain on grabbing (+), no findings of arthritis; no chest/abdominal findings; Blood test: inflammation (-); thyroid function: normal; screening for collagen diseases (-). School attendance: The patient was able to attend classes but often fell forward due to a sudden weakness of the knees during the 20 minute-walk to school. She often fell over in the campus. The patient used a cane provided by an orthopedic clinic for leg injury. The patient observed the gymnastic class. The patient was using the slope with a handrail in the campus. Since October 2013, the patient had been using a cane on a daily basis. Diagnosis: After HPV vaccination, the patient presented with multilayered symptoms, over time, of pain disorder (including headache and body pain), numbness, malaise, sleep disorder, difficulty walking, weakness, motor dysfunction such as fall, abnormal menstruation, dizziness on standing up, giddiness, palm sweating, autonomic dysfunctions such as digestive symptoms, mental concentration decreased and higher brain dysfunction such as mood swings and thus was diagnosed with HPV associated neuropathic syndrome. At the time of the report on 21-DEC-2015, the outcomes of pain disorder(including headache and body pain), numbness, malaise, sleep disorder, difficulty walking, weakness, motor dysfunction such as fall, abnormal menstruation, dizziness on standing up, giddiness, palm sweating, autonomic dysfunctions such as digestive symptoms, mental concentration decreased, higher brain dysfunction such as mood swings and HPV associated neuropathic syndrome were unknown. At the time of the report on 31-MAR-2016, the outcomes of pain disorder (including headache and body pain, (including headache and body pain), numbness, malaise, sleep disorder, difficulty walking, weakness, motor dysfunction such as fall, abnormal menstruation, dizziness on standing up, giddiness, palm sweating, autonomic dysfunctions such as digestive symptoms, mental concentration decreased, higher brain dysfunction such as mood swings and HPV associated neuropathic syndrome were unknown. The patient was planned to be transferred to another hospital in the future. Postural orthostatic tachycardia syndrome (POTS)/ orthostatic intolerance. Questions: 1. What symptoms were noted in the patient (orthostatic intolerance, dizziness, headache, nausea and heart rate increased in particular)?: Dizziness: Yes, Headache: Unknown, Nausea: Unknown, Heart rate increased: Unknown. 2. Was the symptom aggravated in upright position and improved in the spine position (leaning against something or at rest)?: Unknown. 3. Was the heart rate increased when the position was changed to upright position after the spine position (on the back) except for the case of orthostatic hypotension (blood pressure lower than 20/10 mmHg): Unknown. 4. If yes, how much was the heart rate increased by bpm?: Unknown. 5. How long did the patient remained standing when tachycardia developed?: Unknown. 6. How long was the symptom persisting?: Unknown. 7. Was there obvious cause of the orthostatic symptom or tachycardia (state of bleeding, acute dehydration or drug administration, etc. )?: None, State of bleeding: None, Acute dehydration: None, Administration of drug that was considered to be involved in the occurrence of the symptom: None. Performed diagnostic test and the results: 1) Tilt table test: Not performed. 2) Other diagnostic test: Not performed Treatments: 1. Any treatment given?: No treatment. 2. Treatment outcome: Not provided. Reporter''s comment: The causality was unknown but could not be ruled out. The reporting physician considered that pain disorder (including headache and body pain), numbness, malaise, sleep disorder, difficulty walking, weakness, motor dysfunction such as fall, abnormal menstruation, dizziness on standing up, giddiness, autonomic dysfunctions such as digestive symptoms, mental concentration decreased, higher brain dysfunction such as mood swings and HPV associated neuropathic syndrome were serious due to other important medical event. The reporting physician considered that palm sweating was non-serious. The reporting physician felt that the causal relationship of pain disorder (including headache and body pain), numbness, malaise, sleep disorder, difficulty walking, weakness, motor dysfunction such as fall, abnormal menstruation, dizziness on standing up, giddiness, autonomic dysfunctions such as digestive symptoms, mental concentration decreased, higher brain dysfunction such as mood swings, HPV associated neuropathic syndrome and palm sweating to GARDASIL was unknown and considered that the other causative factor was unknown. No further information is available. Reporter, lab test, product, events and narrative were updated.


VAERS ID: 634108 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-06-16
Onset:0000-00-00
Submitted: 2016-04-05
Entered: 2016-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0277AA / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Asthenia, Autonomic nervous system imbalance, Blood test normal, Cataplexy, Cerebral disorder, Computerised tomogram head normal, Constipation, Diarrhoea, Disturbance in attention, Dizziness, Dizziness postural, Dysgraphia, Dyskinesia, Dysmenorrhoea, Dysphagia, Fibromyalgia, Headache, Hyperacusis, Hypersomnia, Hypoaesthesia, Initial insomnia, Irritability, Malaise, Menstruation irregular, Mental impairment, Mobility decreased, Motion sickness, Muscle spasms, Muscular weakness, Myalgia, Nausea, Neuropathy peripheral, Nuclear magnetic resonance imaging brain normal, Pain, Peripheral coldness, Photosensitivity reaction, Reading disorder, Sensory disturbance, Syncope, Temperature regulation disorder, Tenderness, Thyroid function test normal, Tremor, Vaccination complication, Vaccination site pain, Weight increased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (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), Pseudomembranous colitis (broad), 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), Hostility/aggression (broad), 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), Hypersensitivity (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: She gained weight even though the amount of food intake was not so large (obesity despite small food intake). Findings of physical examination: Fibromyalgia (FM) tenderness and muscle pain on grabbing: Yes; Finding of arthritis: No; Chest and abdomen: No abnormal findings; Blood test: Inflammatory findings: No; Thyroid function: No abnormality; Screening for collagen diseases: No abnormality; Head CT and MRI: The patient was told from the hospitals where she had visited that there was no abnormality.
CDC Split Type: WAES1512JPN014211

Write-up: This spontaneous report as received from the agency refers to a 12 year old female patient. The patient''s historical conditions, concurrent conditions and concomitant medications were not reported. On 07-APR-2012, 16-JUN-2012 and on 10-MAR-2013, the patient was vaccinated with HPV vaccine (manufacturer unknown) injection, intramuscular (dose not reported). On unknown dates the patient experienced malaise, neuropathy, menstruation irregular, cerebration impaired, sensory disturbance, dysautonomia, movements involuntary, cataplexy, temperature regulation disorder, numbness, headache and pain. The outcome of malaise, neuropathy, menstruation irregular, cerebration impaired, sensory disturbance, dysautonomia, movements involuntary, cataplexy, temperature regulation disorder, numbness, headache and pain was reported as unknown. The reporter considered malaise, neuropathy, menstruation irregular, cerebration impaired, sensory disturbance, dysautonomia, movements involuntary, cataplexy, temperature regulation disorder, numbness, headache and pain to be related to HPV Vaccine (manufacturer unknown). Follow-up information has been received from a physician and also via Agency (agency # V1510102) on 31-MAR-2016 concerning the patient. Special notes on the pre-vaccination interview form (including underlying disease, allergy, vaccination and diseases within the recent 1 month, medications currently taken, adverse reaction history and growth status) were not reported. Information on underlying/ concomitant disease and medical history was not obtained. No other concomitant medication was reported. Before the vaccination of HPV vaccine: The patient had been doing volleyball since she was a first grader of the elementary school and was continuing after she entered the junior high school. Her school grades were excellent both in the elementary school and junior high school. Vaccinations of HPV vaccine (name of the vaccine: GARDASIL). Dates of vaccination: On 07-APR-2012, the patient was vaccinated with GARDASIL for the first time (Lot no.: 9QN03R). On 16-JUN-2012, the patient was vaccinated with GARDASIL for the second time (Lot no.: 9QN03R). On 10-MAR-2013 (also reported as 10-MAR-2015), the patient was vaccinated with GARDASIL for the third time (Lot no.: unknown). Medical institution where the vaccinations were performed: Clinic K (in City Y). Chief complaints at consultation with a staff of City Y -Weakness in the hands and feet -Inability to get up from the bed in the morning -Tremulousness of the fingertips -Cramps of the palms -Coldness in the hands -Numbness in the hands when holding cold things -Dizziness on walking -Strange feeling as if unable to swallow well when eating or drinking something. Hospital visits for the post-vaccination symptoms: Before the vaccinations -Department of orthopedic surgery in Hospital K - Department of orthopedic surgery Y: Symptoms including jerky movements of the joints (particularly, the ankles) appeared, for which the patient visited the department of orthopedic surgery and was said from an orthopedist as follows: The joints were soft and the point of growth was noted. The joints would become a little more solid after the patient had grown-up and the symptoms might become better. Currently, the ankle symptoms were improved. -Medical science center in City Y. Clinical course after vaccination with HPV vaccine: After the second vaccination with HPV vaccine, the patient had severe pain in the vaccination site and the pain persisted for a while. Thereafter, the patient became unable to wake up due to symptoms including malaise, numbness in the body and headache. In addition, she could not get up due to weakness in the hands and feet. Since she could not move from the upper floor of a bunk bed and was helped by her family member, the patient became to sleep in the lower floor but still could not get up. Around that time, her hands were always cold and her temperature was low. From around the summer of 2012, the patient became aware that her complexion was bad and she was ill. She had tremulousness of the fingertips, cramps of the palms, coldness in the hands, numbness in the hands when holding cold things and dizziness on walking, and headache aggravated along with the change of atmosphere (at low atmospheric pressure). Concerning her school attendance, she tended to be absent from school from the first grade of junior high school and frequently could not go to school as well while she was in the second and third grades. In the end of a school year, the patient was thus told from the school that she was absent too much and she was forced to go to school once a week recently. She was absent from the physical education class almost every time. On 14-AUG-2014, the patient visited the reporting department for the first time. Chief complaints included abnormal malaise, persistent headache from the morning, weakness, inability to get up from the bed in the morning, tremulousness of the fingertips (involuntary movements with tremulousness), cramps of the palms, coldness in the hands, numbness in the hands when holding cold things, dizziness on walking and strange feeling as if unable to swallow well when eating or drinking something. Sunlight and fluorescent light were too bright for her (photosensitivity) and the patient was also hypersensitive to sounds (she had shivering when she heard children''s voices). The patient had irregular menstruation but no change in the color of the menses blood was noted. She had severe dizziness on standing up and car sickness and was repeating diarrhoea and constipation. Attacks of weakness resulting in collapse frequently occurred (cataplexy). No sleep attacks were note. Her calculation ability definitely decreased and errors in reading a book increased. She gradually became unable to write characters. In addition, she also made frequent mistakes in writing letters and numbers. She gained weight even though the amount of food intake was not so large (obesity despite small food intake). She could not play volleyball well (she had been playing volleyball since she was a first grader of the elementary school). Although she had difficulty falling asleep, she slept for 18 hours a day (excessive sleeping). Hyperosmia became apparent and she presented with queasy when she noticed the smells of pork dumplings or sausages. Irregular menstruation seemed to be aggravating gradually and the color of the menses blood became clouded. She also had period pains. At the time of typhoon in summer, her whole physical condition was influenced and she complained of generalized pain at the same time. Weakness was severe as well. She became irritated and often fought with her sibling. Findings of physical examination: Fibromyalgia (FM) tenderness and muscle pain on grabbing: Yes. Finding of arthritis: No; Chest and abdomen: No abnormal findings. Blood test: Inflammatory findings: No; Thyroid function: No abnormality; Screening for collagen diseases: No abnormality. Head CT and MRI: The patient was told from the hospitals where she had visited that there was no abnormality. Diagnosis: According to the aforementioned clinical course and information, in this case, the patient''s symptoms were aggravating on a multi-layered basis (painful disorder aggravated to malaise, headache and numbness, and then to body temperature regulation disorder, to weakness (cataplexy), to involuntary movements with tremulousness, to autonomic dysfunction: dizziness on standing up, car sickness and dizziness, to sensory disturbance; photosensitivity, hypersensitivity to sounds and hyperosmia, to irregular menstruation, and to higher brain dysfunction; decreased concentration, decreased calculation ability, inability to write characters and decreased understand of the sentence contents). Therefore, the patient was diagnosed as "human papillomavirus vaccination (HPV) associated neuropathic syndrome". As of the time of the report on 31-MAR-2016, the outcomes of painful disorder, malaise, headache, numbness, body temperature regulation disorder, weakness (cataplexy), involuntary movements with tremulousness, autonomic dysfunction: dizziness on standing up, car sickness and dizziness, sensory disturbance: photosensitivity, hypersensitivity to sounds and hyperosmia, irregular menstruation, higher brain dysfunction; decreased concentration, decreased calculation ability, inability to write characters and decreased understanding of the sentence contents and HPV associated neuropathic syndrome were unknown. The patient was scheduled to be transferred to other hospital in the future. Reporter''s comments: Not provided. The reporting physician considered autonomic dysfunction: dizziness on standing up, car sickness and dizziness, sensory disturbance: photosensitivity, hypersensitivity to sounds and hyperosmia, irregular menstruation, higher brain dysfunction: decreased concentration, decreased calculation ability, inability to write characters and decreased understanding of the sentence contents, and HPV associated neuropathic syndrome were serious due to other important medical event. The reporting physician did not assess the seriousness of painful disorder, malaise, headache, numbness, body temperature regulation disorder, weakness (cataplexy) and involuntary movements with tremulousness. The reporting physician felt that the causal relationship of painful disorder, malaise, headache, numbness, body temperature regulation disorder, weakness (cataplexy) and involuntary movements with tremulousness, sensory disturbance: photosensitivity, hypersensitivity to sounds and hyperosmia, irregular menstruation, higher brain dysfunction: decreased concentration, decreased calculation ability, inability to write characters and decreased understanding of the sentence contents, and HPV associated neuropathic syndrome was unknown and considered that other causative factor was unknown. The reporting physician felt that autonomic dysfunction: dizziness on standing up, car sickness and dizziness was related to GARDASIL and considered that other causative factor was unknown. No further information is available. Reporter, patient, product, event and narrative have been updated.


VAERS ID: 634541 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-12
Entered: 2016-04-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anogenital warts, Arthralgia, Back pain, Headache, Menstrual disorder, Mental disorder, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Arthritis (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: CR2016GSK046913

Write-up: This case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a 26-year-old female patient who received CERVARIX. Co-suspect products included CERVARIX and CERVARIX. On an unknown date, the patient received the 1st dose of CERVARIX, the 2nd dose of CERVARIX and the 3rd dose of CERVARIX. On an unknown date, 1 year after receiving CERVARIX, CERVARIX and CERVARIX, the patient experienced vaccination failure (serious criteria GSK medically significant), genital wart (serious criteria clinically significant/intervention required), menstrual disorder, joint pain, back pain and headache. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the genital wart, menstrual disorder, joint pain, back pain and headache were not reported. It was unknown if the reporter considered the vaccination failure and genital wart to be related to CERVARIX, CERVARIX and CERVARIX. It was unknown if the reporter considered the menstrual disorder, joint pain, back pain and headache to be related to CERVARIX. Additional information was provided as follows: The patient received complete schedule of CERVARIX vaccine, 3 years before reporting. In 2014, approximately 1 year after completion of CERVARIX schedule, the patient experienced genital warts. The patient was subjected in a lot of procedures. The patient had needed psychological and psychiatric intervention (this intervention was required because of the number of procedures). On an unspecified date, after vaccination with 3rd dose of CERVARIX, the patient experienced menstrual disorders, joints pain, backache and headache. This case was considered as suspected vaccination failure, as the patient''s HPV (Human papillomavirus) status before vaccination was unknown.


VAERS ID: 634739 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2013-07-19
Onset:2013-08-01
   Days after vaccination:13
Submitted: 2016-04-14
   Days after onset:987
Entered: 2016-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA165AA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal tenderness, Activities of daily living impaired, Asthenia, Autoantibody negative, Autonomic nervous system imbalance, Back pain, Blood test normal, Cognitive disorder, Dizziness, Dizziness postural, Dyscalculia, Dyskinesia, Dysmenorrhoea, Dyspepsia, Gastrointestinal disorder, Hallucination, Hallucination, auditory, Headache, Hyperacusis, Hyperhidrosis, Hypoaesthesia, Hypotension, Intentional self-injury, Irritability, Limb discomfort, Malaise, Memory impairment, Menstrual disorder, Mental impairment, Myalgia, Nausea, Pain, Palpitations, Photophobia, Post vaccination syndrome, Prosopagnosia, Pruritus, Rash, Restlessness, Seizure, Sensory disturbance, Sleep disorder, Tachycardia, Tenderness, Thyroid function test normal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Suicide/self-injury (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Akathisia (broad), Dyskinesia (narrow), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), 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), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), 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? Yes
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): Blood tests: Inflammatory findings: None; Thyroid functions: Normal; Screening for autoantibodies: Negative
CDC Split Type: JP2016JPN047975

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of post vaccination syndrome in a female patient who received CERVARIX (batch number AHPVA164AA, expiry date unknown) and (batch number AHPVA165AA, expiry date unknown). On 1st February 2013, the patient received the 1st dose of CERVARIX (intramuscular). On 1st March 2013, the 2nd dose was an unknown dose. On 19th July 2013, the 3rd dose was an unknown dose. In August 2013, several weeks after receiving CERVARIX, the patient experienced post vaccination syndrome (serious criteria GSK medically significant and clinically significant/intervention required), self-inflicted laceration (serious criteria GSK medically significant and clinically significant/intervention required), general malaise and sleep disorder. On 7th January 2015, the patient experienced facial rash, pruritus and pain. On an unknown date, the patient experienced cerebration impaired (serious criteria GSK medically significant), memory impairment, dyscalculia, cognitive function abnormal, prosopagnosia, headache, myalgia, low back pain, menstrual disorder, menses painful, sensory disturbance, photophobia, hyperacusis, feeling queasy, dysautonomia, dizziness, dizziness on standing up, hypotension, palpitations, tachycardia, functional dyspepsia, skin eruption, hallucination, auditory, hallucination, weakness, generalised convulsion (serious criteria GSK medically significant), movements involuntary, sweaty hands, numbness of limbs, lower extremities discomfort, irritability, tenderness, upper abdominal tenderness and gastrointestinal disorder. On an unknown date, the outcome of the post vaccination syndrome, self-inflicted laceration, cerebration impaired, memory impairment, dyscalculia, cognitive function abnormal, prosopagnosia, headache, myalgia, low back pain, menstrual disorder, menses painful, sensory disturbance, photophobia, hyperacusis, feeling queasy, dysautonomia, dizziness, dizziness on standing up, hypotension, palpitations, tachycardia, functional dyspepsia, general malaise, sleep disorder, facial rash, skin eruption, pruritus, pain, hallucination, auditory, hallucination, weakness, generalised convulsion, movements involuntary, sweaty hands, numbness of limbs, lower extremities discomfort, irritability, upper abdominal tenderness and gastrointestinal disorder were not recovered/not resolved. It was not reported if the reporter considered the post vaccination syndrome, self-inflicted laceration, cerebration impaired, memory impairment, dyscalculia, cognitive function abnormal, prosopagnosia, headache, myalgia, low back pain, menstrual disorder, menses painful, sensory disturbance, photophobia, hyperacusis, feeling queasy, dysautonomia, dizziness, dizziness on standing up, hypotension, palpitations, tachycardia, functional dyspepsia, general malaise, sleep disorder, facial rash, skin eruption, pruritus, pain, hallucination, auditory, hallucination, weakness, generalised convulsion, movements involuntary, sweaty hands, numbness of limbs, lower extremities discomfort, irritability, tenderness, upper abdominal tenderness and gastrointestinal disorder to be related to CERVARIX. The subject had received the first and the second vaccinations in the first grade of junior high school and the third vaccination in the second grade of junior high school. In August 2013, several weeks after the vaccinations, general malaise, headache, and sleep disorder had developed. The subject had visited more than ten different psychosomatic medicine clinics in total before and after the subject had moved her residence. The subject claimed that the symptoms had developed after the CERVARIX vaccinations. However, the subject''s claim was dismissed by all the clinics. During this period of time, the subject repeated self-inflicted laceration three times. On 07 January 2015, the subject visited the reporting department for the first time. Reddish brown (port wine red) facial rash developed. The subject had had acnes since before the CERVARIX vaccinations. However, the color and the onset sites were completely different. The skin eruption was associated with itching, and as well as pain when touched, and had gradually extended even to the back. As of March 2016, the skin eruption was ongoing. On 19 July 2013 (after the third vaccination), the subject had suffered from persistent sleeplessness during her summer break just after the third vaccination, and experienced malaise and headache, for which the subject visited four different nearby physicians. However, no cause was identified. The subject was prescribed ointments and oral medicines, which achieved no improvement. During this period of time, the subject started experiencing auditory hallucination and/or hallucination. In addition, the subject started suffering from sudden feelings of weakness, and often lost her balance and fell. Generalised convulsion had also developed twice (possible involuntary movement). The subject started finding sunlight and indoor lighting dazzling, and became unable to go out. The subject started wearing sunglasses when going out. The subject always experienced headache and queasy when dazzled by light. The subject became sensitive to small noise at her surroundings. Giddiness and dizziness on standing up developed occasionally. Severe sweaty hands developed. The subject experienced numbness of limbs, myalgia, low back pain especially, and pain at the cleft of the buttock and around the coccyx. Headache started developing upon awakening, which became intense when the fluorescent lighting of her room was on, and persisted all day. Giddiness developed when the subject got warmed up in a bath. The subject fell from giddiness when the subject had a hot spring trip with her family. Dizziness on standing up gradually worsened, and the subject could not help her body moving backward without being cautious while standing. Even at the time of reporting, the subject got pixilated if the subject took a bath for 5 minutes or so, and giddiness started developing. The subject had her periods cyclically, but period pains became severe. Vaginal discharge of unknown cause persisted for about a year. Forgetfulness worsened. The subject took longer time to simple calculations, and lost her confidence in calculating money. The subject became unable to tell the hour even looking at the clock. The subject used to love reading books. However, as the subject became unable to understand the contents of books unless reading repeatedly, the subject no longer read books recently. The subject hardly attended school in the second and the third grade of junior high school, which was after the CERVARIX vaccinations. The subject could not sit on entrance exams for high schools due to various symptoms, and could not enter a high school. The subject entered to a correspondence course. The subject tried to attend schooling as much as possible. Recently, the subject cannot picture her friends'' faces. The subject could not even recall them. As the subject felt restless below her knees when the subject got into bed, the subject got irritated and started walking around her room. The subject had severe palpitations, and tachycardia was pointed out at a medical check-up. Low blood pressure was also pointed out. Unique skin eruption, numbness and weakness, pain disorders including headache, myalgia, and low back pain, menstruation abnormal, sensory disturbance including photosensitivity and hyperacusis, autonomic nervous system disorders including giddiness, dizziness on standing up, low blood pressure, palpitations, and functional dyspepsia, and higher cerebral dysfunction including memory impairment and prosopagnosia had developed soon after the CERVARIX vaccinations. These symptoms had gradually been multi-layered. Accordingly, human papillomavirus vaccination associated with neuropathic syndrome (HANS) (post vaccination syndrome) was diagnosed. Physical examination findings: Fibromyalgia tender points were 18/18. Severe tenderness was noted along the tendon and ligament around the patella. Marked tenderness was noted along the triceps brachii tendon and quadriceps tendon was noted. The subject did not complain of abdominal pain at a medical interview. However, marked tenderness was noted at the gastric region. Contracted stomach was noted at a palpation. At the first visit, blood pressure was 109/90 mmHg, pulse rate was 74 bpm, and body temperature was 36.5 degrees C. Results of relevant tests and procedures associated with the diagnosis: Blood tests: (On an unknown date): Inflammatory findings: None. Thyroid function: Normal. Screening for autoantibodies: Negative. The subject exhibited various complicated symptoms. Higher cerebral dysfunction, in particular, was considered as an important factor for the subject''s prognosis.


VAERS ID: 632380 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-11-13
Onset:2008-12-01
   Days after vaccination:18
Submitted: 2016-04-20
   Days after onset:2696
Entered: 2016-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Anxiety, Chest pain, Cognitive disorder, Cyanosis, Depression, Dizziness, Ear pain, Eating disorder, Fall, Fatigue, Headache, Mental disorder, Muscular weakness, Neck pain, Pain in extremity, Photophobia, Sensory disturbance, Speech disorder, Syncope, Tremor, Trismus
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (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 (broad), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: 2012, Vitamin B12 deficiency; 2012, Leukopenia; 2012, Neutropenia; Coeliac disease; Scoliosis, crooked back; Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1604DNK011869

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control number DK-1577272925-2016004035) on 18-APR-2016. Case received 14-APR-2016 via HA from the Patient Compensation (PIC), case number 16-2138. Note that the patient''s initial report to PC has been received by the Medical Agency. This case is therefore not considered by PIC. DESCRIPTION: The patient faints the first time in December 2008 when she stands up and is just to say "I''m bad!" then she becomes quite blue in the face and drops. She is away for a minute or two. Around the same time she begins to have severe pain in the neck and head as well as frequent fainting. After fainting she is tired and have sore arms and legs. Fainting accompanied by tremors in the limbs, which then are sore, and when she fainted she felt that jaw locked, and the patient had difficulty talking. She was admitted to Hospital in September 2009, to be thoroughly investigated. Physiotherapists and some doctors believe that the problems comes from her crooked spine while a doctor at Hospital disapprove. Regardless of what has been attempted, the symptoms remain unchanged. There are times when it seems to be better with the faintings, then sudden relapse occurs. Whereas pain in the neck, head, arms and legs are constant. As the years pass, she becomes increasingly psychologically affected by the insecurity of the situation and is elucidated by psychologist and is told that she suffers from anxiety and depression, and eating disorders. First on 2013, when the press focuses on a number of girls have been sick of the HPV vaccine, she was aware that her symptoms was indistinguishable, and that her fainting and other problems started within a month after her vaccination. She still suffers much from fatigue, periodic fainting, dizziness, severe headache, sore neck, pain in the limbs, chest pain, abnormal sensations and weakness in the legs, very sensitive to light, pain in the ears, cognitive problems, etc. The faintings come very suddenly, and in all situations (when she walks, stands, at rest, etc.). She has for example fainted as she walked behind her boss during a school job in a shoe shop, and sitting in a train on the way to school, in the doctor''s waiting room and while standing in line at the checkout in a supermarket etc. She cannot, for example take a driver''s license and can no longer care for any after-school jobs beside her studies. She has also had to go a year on a special program because of the many absences from school, due to the above problems and had to stop completely with physical training in spring 2015. In the spring of 2014 case as a prolonged period of daily syncope without preceding dizziness or other warning signs, and she instead of ''fall over'' almost just collapsed on the spot. A 14-year-old female adolescent patient received GARDASIL (batch number LOT NOT REP, Dose 1) on 13-Nov-2008, GARDASIL (batch number LOT NOT REP, Dose 2) on 05-Feb-2009, GARDASIL (batch number LOT NOT REP, Dose 3) on 31-Aug-2009. The patient experienced fainting in DEC-2008, violent neck pain in DEC 2008, violent headache / pain in head in DEC-2008, violent tiredness in DEC-2008, pain in arms and legs / sore limbs in DEC-2008, trembling limbs on an unknown date, felt that the jaw locked, so she had difficulty talking on an unknown date, mentally affected on an unknown date, chest pain on an unknown date. Sensory disturbances on an unknown date, weakness in legs on an unknown date, very sensitive to light on an unknown date, ear pain on an unknown date, cognitive problem on an unknown date, not fix an after-school job, had to go a year on the special program / stop training completely in the spring of 2015 on an unknown date, anxiety on an unknown date, Depression on an unknown date, eating disorder on an unknown date and dizziness on an unknown date. The patient was admitted to hospital on an unspecified date. The patient had a medical history of: scoliosis; coeliac disease; neutropenia in 2012; Leukopenia in 2012; Vitamin B12 deficiency in 2012. The patient''s outcome was reported as unknown.


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