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Found 247 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: 308895 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-11-27
Onset:2008-01-01
   Days after vaccination:35
Submitted: 2008-04-03
   Days after onset:92
Entered: 2008-04-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Ataxia, CSF lymphocyte count increased, CSF oligoclonal band present, Encephalopathy, Mental disorder due to a general medical condition, Myoclonus, Pleocytosis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Chronic kidney disease (broad), Malignant lymphomas (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: cerebrospinal fluid culture 01Jan08 Comment: pleocytosis, oligoclonal bands positive
CDC Split Type: WAES0804USA00535

Write-up: Information has been received from a health authority concerning a 16 year old female who on 27-NOV-2007 was vaccinated IM with a first dose of GARDASIL. On 01-JAN-2008 the patient experienced encephalopathy with myoclonus opsoclonus syndrome. It was reported that the clinical picture was described as encephalopathy with myoclonus, opsoclonus, ataxia and organic brain syndrome. The patient was hospitalized. A cerebrospinal fluid examination showed pleocytosis, oligoclonal bands positive. At the time of this report, the patient has no recovered. Encephalopathy and myoclonus opsoclonus were considered to be immediately life-threatening. Other business partner numbers include: E200802621 and PEI2008002769. No further information is available.


VAERS ID: 315862 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-04-02
Onset:2007-05-01
   Days after vaccination:29
Submitted: 2008-06-05
   Days after onset:401
Entered: 2008-06-10
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1019F / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Depression, Mental disorder, Pain, Suicide attempt
SMQs:, Suicide/self-injury (narrow), Dementia (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA00405

Write-up: Information has been received from a consumer concerning her 16 year old daughter who on 02-APR-2007 was vaccinated IM, into the deltoid, with a first dose of GARDASIL (lot #655635/1019F; batch NF03290). In the beginning of May 2008, the patient experienced depression. In November 2007 she had a "nervous breaking." She complained of pain in the whole body and attempted suicide. She was admitted to a psychiatric hospital on 09-APR-2008. Despite ongoing symptoms, the patient was vaccinated with a second dose of GARDASIL (lot #654948/0903F; batch NE47410) on 02-JUN-2007 and third dose of GARDASIL (lot #1536F; and batch NG01520). Other business partner included E2008-04868. No further information is available.


VAERS ID: 319824 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-01-30
Onset:2008-01-30
   Days after vaccination:0
Submitted: 2008-07-18
   Days after onset:169
Entered: 2008-07-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Back pain, Diplopia, Disturbance in attention, Dysarthria, Electrocardiogram normal, Gait disturbance, Headache, Hyperacusis, Influenza, Influenza serology positive, Lumbar puncture normal, Meningism, Mental impairment, No reaction on previous exposure to drug, Nuclear magnetic resonance imaging normal, Photosensitivity reaction, Ultrasound abdomen normal, Vision blurred
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Lens 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), Ocular motility disorders (broad), Hypersensitivity (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Infection susceptibility increased
Allergies:
Diagnostic Lab Data: spinal tap, Comment: normal; magnetic resonance imaging, Comment: normal; abdominal ultrasound, Comment: normal; electrocardiogram, Comment: normal; serum influenza B virus Ab, Comment: slightly positive antibodies for Influenza B virus
CDC Split Type: WAES0806USA00535

Write-up: Initial and follow up information has been received from a physician concerning a 19 year old female with a history of relapsing infections who on 30-JAN-2008 was vaccinated intramuscularly into the upper left arm with her third dose of GARDASIL (Lot # and site not reported). Two days post vaccination the patient complained about headache and asthenia. She was admitted to the hospital for diagnostics (not further specified) and recovered completely within about 1 week. The first and second vaccinations with GARDASIL (Dates, Lot #s, route and sites not reported) were well tolerated. No additional information was provided. In follow up it was reported that on 30-JAN-2008 (also reported as "same day"), she developed meningeal irritation, double and blurred vision, concentration disorder, noise- and photosensitivity, a "dull feeling in head", articulation problems, gait disorder, headache, asthenia and back pain. On 31-Jan-2008 she was admitted to the hospital for diagnostics. Virus diagnostics revealed low-positive antibodies for Influenza B virus. Other virus infections were ruled out. Meningeal irritation due to influenza B virus infection was assumed. A postvaccinal reaction was discussed. A lumbar puncture was performed (normal results) and meningitis could be ruled out. Cranial MRI, abdominal sonography, ECG and neurological examinations showed normal results. Therapy was carried out with unspecified infusions and analgesics. The patient fully recovered and was discharged from the hospital on 06-FEB-2008 (exact duration of symptoms not reported). The file is closed. Other business partner numbers include: E2008-04957. No further information is available.


VAERS ID: 335154 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-11-28
Onset:2008-11-30
   Days after vaccination:2
Submitted: 2008-12-11
   Days after onset:11
Entered: 2008-12-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Abdominal tenderness, Alanine aminotransferase increased, Aspartate aminotransferase increased, Bilirubin conjugated normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Dilatation intrahepatic duct acquired, Gamma-glutamyltransferase increased, Hepatitis, Lip dry, Mental status changes, Pallor, Pyrexia, Somnolence, Ultrasound abdomen abnormal, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Biliary tract disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Abdominal ultrasound, 01Dec08, dilation of important hepatic ducts, R. polycystic kidney; Abdominal ultrasound, 01Dec08, L. kidney w/modified structure on ultrasonography; Serum alanine aminotransferase, 01Dec08, 503 u/l, abnormal high: hepatitis; Serum alkaline phosphatase, 01Dec08, 218 u/l, not provided; Serum aspartate aminotransferase, 01Dec08, 696 u/l, abnormal high: hepatitis; Serum direct bilirubin, 01Dec08, 0.1 mg/dl, normal; Serum gamma glutamyl transferase, 01Dec08, 37 u/l, not provided; Total serum bilirubin, 01Dec08, 0.6 mg/dl, normal
CDC Split Type: WAES0812HUN00003

Write-up: Information was received from a physician concerning a 10 year old female patient with no medical history mentioned who on 28-NOV-2008 received on arm (not specified if left or right arm) the first dosage (shot) of GARDASIL, 0.5 ml, prefilled syringes, intramuscular, out of 3 for immunization against HPV types 6, 11, 16, 18. No concomitant medications were reported. In about two days after vaccination, the patient presented fever (38 C, axillar), sleepiness, biliary vomiting, abdominal pain (periumbilical/periophalic and epigastric). The patient was referred to the hospital where the acute hepatitis diagnosis was suspected. On clinical examination were reported: altered general status, somnolence, dry lips, pale teguments, subcutaneous cellular tissue weak represented, balanced cardio-vascular and respiratory, slight sensitive abdomen on palpitation on periumbilical area. On laboratory test were found elevated serum levels of AST (GOT), ALT (GPT), Gamma-GT, alkaline phosphatase. Total and direct bilirubinemia were found in normal values. On abdominal ultrasonography examination were found signs of hepatitis with enlargement of an all intra-and extra-hepatic ducts. Also, there were found right polycystic kidney and left kidney with modified structure on ultrasonography. During one day of hospitalization in the pediatric department treatment with an antibiotic (not mentioned which one and dosages) and perfusion with glucose and natrium chloride solutions (not mentioned the volume and concentrations) were administered. The patient was referred to the infectious disease department with a diagnosis of acute hepatitis and the outcome was reported as not recovered. In the opinion of the reporting physician, the reported adverse events could be in relation with administration of GARDASIL. Additional information is expected.


VAERS ID: 338235 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-09-18
Onset:2008-08-26
   Days after vaccination:343
Submitted: 2009-01-23
   Days after onset:150
Entered: 2009-01-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Biopsy brain abnormal, CSF cell count increased, Cognitive disorder, Convulsion, Emotional disorder, Gliosis, Mental disorder due to a general medical condition, Psychotic disorder, Vasculitis cerebral
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Vasculitis (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Immunisation
Allergies:
Diagnostic Lab Data: brain biopsy, 26Aug08, reactive astrocytic gliosis; cerebrospinal fluid culture, increased number of cells
CDC Split Type: WAES0901USA02687

Write-up: Information has been received from the foreign Health Authorities (Reference no.: PEI2008021098), concerning a 17 year old female patient, who on 18-SEP-2007, was vaccinated with the first dose of GARDASIL (toleration was not reported); on 20-NOV-2007, was vaccinated with the second dose of GARDASIL (toleration not reported) and on 11-MAR-2008, was vaccinated with third dose of GARDASIL, intramuscularly (Lot # and injection site not reported). Starting mid-Jun-2008, the patient developed cerebral vasculitis with acute psychotic symptoms and seizures. Cerebral biopsy, performed on 26-AUG-2008, revealed astrocytic gliosis. Lab finding showed increased number of cells in cerebrospinal fluid (=CSF). Despite of therapies with cortisone, neuroleptics and antiepileptics, the patient only improved slowly from the severe organic brain syndrome with slowdown, cognitive disorders and emotional symptoms. The cause of cerebral vasculitis remained unexplained. The patient had not recovered. Other business partner numbers included (E2009-00275). No further information is available.


VAERS ID: 344162 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-08-14
Onset:2008-11-01
   Days after vaccination:79
Submitted: 2009-04-14
   Days after onset:164
Entered: 2009-04-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1172U / 3 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activities of daily living impaired, Headache, Mental disorder, Nausea, Nervousness, Nuclear magnetic resonance imaging normal, Paraesthesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Magnetic resonance imaging, normal
CDC Split Type: WAES0904USA01038

Write-up: It was reported by a gynecologist that a 14-year-old female patient was vaccinated with a third dose of GARDASIL (batch number NH13130, lot number 1172U) IM into the upper arm on 14-AUG-2008. In NOV-2008 the patient developed recurrent syncope, tingling of the legs, headache, nervousness and nausea. The patient was hospitalized on an unspecified date for diagnostics. Neurological and internal investigations including cranial magnetic resonance imaging (MRI) showed normal results. A psychogenic cause was evoked by the hospital physicians. The patient not recovered at the time of reporting. Meanwhile the girl''s teachers refused to bear the responsibility, so she cannot visit school anymore. D1 (batch number NH04240, lot number 1113U) and D2 (batch number NH06410, lot number 1068U) of GARDASIL, administered on unspecified dates were well tolerated. Other business partner numbers included E200902921. Additional information has been requested.


VAERS ID: 351099 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-07-09
Entered: 2009-07-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Areflexia, Biliary colic, Dizziness, Faeces discoloured, Guillain-Barre syndrome, Hypokinesia, Malaise, Mental status changes, Pain in extremity, Sensory loss, Ultrasound abdomen abnormal, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Gallbladder related disorders (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Demyelination (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (broad), Tendinopathies and ligament disorders (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? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Blood pressure measurement, 10Feb09, 95/60; WBC count, slightly increased
CDC Split Type: WAES0906USA03817

Write-up: Initial information was reported on 15-JUN-2009 by the mother of the patient. Additional information was received on 16-JUN-2009 from a health care professional concerning a 17 year old female who in April 2008 was vaccinated with the first dose of GARDASIL (batch number unknown) and the second dose of GARDASIL (batch number unknown) on 30-JUN-2009. In August 2008 the patient was hospitalized and diagnosed with GUILLAIN-BARRE syndrome. The outcome was not reported. Case is closed. Follow-up information has been received from patient''s physician on 30-JUN-2009. According to the medical records the patient was hospitalized from 17-AUG-2008 to 26-AUG-2008 after being diagnosed with GUILLAIN-BARRE syndrome. During the period from September to December 2008 the patient was hospitalized for one month and then received non-institutional care (physical therapy) three times per week. On 08-JAN-2009 the patient reported malaise, pain in arms and legs, abdominal pain and bright colored feces to the doctor (onset on unspecified date). The patient was treated with CITODON (BIOPHAUSIA), DEXOFEN (BIOPHAUSIA), and SPASMOFEN (MEDA) to relieve the pain. The doctor was hesitant due to GUILLAIN-BARRE syndrome to prescribed Selective serotonin reuptake inhibitors (SSRIs) for her ability to make decisions. On 10-FEB-2009 she visited the doctor. The doctor described the patient''s situation after the physical therapy (during September to December 2008) as a very tough period with total loss of sensibility and peripheral loss of the ability to move. The symptoms has gradually gone into regress and she had now regained a lot of her former energy and ability even though she still had some way to go before she would be completely recovered. The patient still experienced heavy loss of reflexes. The most complicated thing had been the attacks of pain in the abdomen that on five occasions had caused her to seek medical attention at the ER (dates not reported). The pain appeared and worsened within 5-10 minutes and could then last for several hours. By this description the doctor thought of colic pain. The patient even vomited due to the pain. Despite several investigations of different test samples (not specified), ultrasound investigations and gynecologist examinations no cause of these symptoms had been established. At one occasion (date unspecified) liquid was found in the area of the appendix, however this happened during a period of regression so there was no reason to carry out any procedure. Apart from slightly increased levels of white blood cells there was no other finding. The patient described bright (almost white) feces in connection to the abdominal pain to the doctor who suspected bile colic. Another possible explanation according to the doctor considering the nature of the pain could be endometriosis. The patients explained to the doctor that she had not experienced the pain for a long time. The doctor then speculated that the symptoms could have been caused by the influence of GUILLAIN-BARRE on the autonomous nervous system causing an autonomous dysfunction. Lately the patient had experienced feelings of being ready to faint. Overall the patient was now happy and alert. The doctor reported that she looked healthy and that was seemed as though she had managed to get through this tough period without any major physical complications. At the doctor''s appointment on 10-Feb-2009 the blood pressure was 95/60 (laying) and systole 95 with a slight increase in pulse when standing. The abdominal pain appeared to be improving and she was exercising on her own with good progress. Ketogen-and morfine injections were only things that had worked against the pain. In case of continuation of the abdominal pain the doctor would refer to a specialist considering a standpoint on endometriosis. On 16-APR-2009 the doctor was in contact with the patient over the phone and prescribed DEXOFEN (50 mg, 100st, 1x1-3). Outcome was not reported. Case is closed. The reporter considered these adverse effects to be serious as other important medical events. Other business partner numbers include: E2009-04968.


VAERS ID: 366697 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-11
Onset:2009-09-11
   Days after vaccination:0
Submitted: 2009-11-11
   Days after onset:61
Entered: 2009-11-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Mental disorder, Nausea, Schizophrenia, Suicidal ideation, Vomiting
SMQs:, Acute pancreatitis (broad), Suicide/self-injury (narrow), Dementia (broad), Psychosis and psychotic disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0601840A

Write-up: This case was reported by a consumer and described the occurrence of schizophrenia disorder in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). On 11 September 2009, the subject received 2nd dose of CERVARIX (unknown route of administration, lot number not provided). On 11 September 2009, less than one day after vaccination with CERVARIX, the subject experienced nausea, vomiting, severe psychiatric disorder and schizophrenia disorder including recurrent thoughts of death and suicide (with a formal reporting recording the police office and the hospital on 18 September 2009). The subject was hospitalised. At the time of reporting the outcome of the events was unspecified.


VAERS ID: 378738 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-06-02
Onset:2009-08-01
   Days after vaccination:60
Submitted: 2010-01-28
   Days after onset:180
Entered: 2010-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA009DE / 2 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Abnormal behaviour, Activities of daily living impaired, Amenorrhoea, Apathy, Aphasia, Blood follicle stimulating hormone increased, Blood luteinising hormone normal, Blood pH decreased, Blood prolactin normal, Blood testosterone decreased, Blood thyroid stimulating hormone normal, Borrelia burgdorferi serology, Borrelia burgdorferi serology negative, Electroencephalogram normal, Fatigue, Fear of pregnancy, Mean cell haemoglobin concentration normal, Mental disorder, Nuclear magnetic resonance imaging normal, Oestradiol normal, Pregnancy test negative, Premenstrual syndrome, Sleep disorder, Thyroxine free normal, Tri-iodothyronine free normal, Ultrasound scan normal, Urine analysis normal
SMQs:, Lactic acidosis (broad), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Fertility disorders (broad), Respiratory failure (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Birth control
Current Illness: unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Borrelia burgdorferi immunoglo, below 6U per ml, 25Nov2009; Borrelia burgdorferi immunoglo, below 1.0, 25Nov2009; Estradiol, 35pg per ml, 27Nov2009; Follicle stimulating hormone, 6.3IU per ml, 27Nov2009; Free T3, 3.7pg per ml, 25Nov2009; Free T4, 1.3mg per dl, 25Nov2009; Luteinising hormone normal, 5.8mIU per ml, 27Nov2009; MCHC, 32g per dl, 27Nov2009; Pregnancy test, negative, 19Nov2009; Prolactin, 4.6mcg per 1, 27Nov2009; Thyroid stimulating hormone, 2.65mcU per ml, 25Nov2009; EEG and MRT of cranium without pathological findings; Borrelia antibodies (IgG-Immunoblot), negative, 25 November 2009; Borrelia antibodies (IgM-Immunoblot), negative, 25 November 2009; gynecological without complaints, last menstrual period on 01 August 2009, cycles were irregular, menarche was in January 2009; gynaecological: tanner was 5, some androgynous hairiness; native: pH was 4, no infection; deoderlein flora degree of hormones 3-2; sonography: bladder filled, uterus existant, endometrium delicate, adnexe inconspicuous on both sides; mammae on both sides inconspicuous, axillae and areas of lymph free on both sides, tanner 5
CDC Split Type: D0066005A

Write-up: This case was reported by a physician and described the occurrence of premenstrual syndrome in a 13-year-old female subject who was vaccinated with CERVARIX (Glaxosmithkline). On an unspecified date the subject received 2nd dose of CERVARIX (unknown route and application site). Approximately one month after vaccination with CERVARIX, the subject experienced premenstrual syndrome. At the time of reporting the outcome of the event was unspecified. Follow up information was received on 21 January 2010 from the reporting physician including physician''s report, report from a gynecologist and two laboratory test results. Previous vaccination included human papilloma type vaccine (Glaxosmithkline, intramuscular, left deltoid) given on 16 April 2009. Following vaccination included human papilloma vaccine (Glaxosmithkline, intramuscular, left deltoid) given on 6 November 2009. On 2 June 2009 the subject received 2nd dose of CERVARIX (intramuscular, left deltoid). On holiday in August 2009, 2 months after vaccination with 2nd dose of CERVARIX, the subject firstly showed unusual psychic behaviour. Back at home the subject was increasingly apathetic, tired, did not talk, was constantly in bed, did not visit school and showed sleep disorder. The subject was admitted to psychiatric hospital. Because of cyclic appearance of the symptoms in relationship to menstrual period premenstrual syndrome was diagnosed. At the time of reporting the subject was treated ambulatory with psychiatric therapy and antidepressant. The physician considered that premenstrual syndrome was unlikely related to vaccination with CERVARIX. At the time of reporting on 13 January 2010 premenstrual syndrome was improved. On 19 November 2009 the subject went to see the gynecologist. The gynaecologist diagnosed secondary amenorrhea, psychic disorder and fear of pregnancy. The subject received contraceptive. The subject experienced 10-11 days psychosomatic dropouts and is gynaecologically free of complaints. The subject was treated with vitex agnus castus. Pregnancy test was negative. No further information will be available.


VAERS ID: 391526 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-12-01
Onset:2009-02-01
   Days after vaccination:62
Submitted: 2010-06-25
   Days after onset:508
Entered: 2010-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA019BD / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Audiogram normal, Blood heavy metal increased, Brain stem auditory evoked response, Diplegia, Dizziness, Ear pain, Electromyogram normal, Full blood count normal, Hair metal test abnormal, Hypoacusis, Laboratory test normal, Lumbar puncture normal, Mental disorder, Monoplegia, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Pain in jaw, Paraesthesia, Somatoform disorder, Stool heavy metal positive, Urine arsenic increased, Urine mercury abnormal, Visual acuity reduced, Wheelchair user, X-ray dental
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (narrow), Vestibular disorders (broad), Osteonecrosis (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Audimetry, Feb2009, see text; Auditory evoked potentials, Mar2009, unknown; Chemistry normal, Feb2009, normal; Electromyogram, Mar2009, normal; Full blood count, Feb2009, normal; Heavy metal NOS high, high level; Lumbar puncture, Mar2009, normal; Nuclear magnetic resonance ang, Feb2009, normal; Nuclear magnetic resonance ang, Mar2009, normal; Nuclear magnetic resonance ima, Mar2009, normal; Panoramic dental X-ray, Mar2009, normal; Panoramic dental X-ray, Mar2009, unknown;
CDC Split Type: B0569872A

Write-up: This case was reported by a regulatory authority (# ES-AGEMED-224866332) and described the occurrence of possible somatoform disorder in a 14-year-old female subject who was vaccinated with CERVARIX, GlaxoSmithKline. Previous vaccination included CERVARIX (GlaxoSmithKline, unknown route) given on 21 October 2008. On 1 December 2008, the subject received 2nd dose of CERVARIX (unknown route). On February 2009, 62 days after vaccination with CERVARIX, the subject experienced unilateral hypoacusis. The subject was hospitalised. Some tests were performed and the results were not available. At the time of reporting the outcome of the events was unspecified. Follow up information received on 20 April 2009 from regulatory authority: On 1 February 2009, 62 days after vaccination with CERVARIX, the subject experienced severe unilateral hypoacusis, facial paresthesia, jaw pain and ear pain. The subject was hospitalised. Relevant tests were performed and showed the following results: Audiometry: sever neurosensor hypoacusis (90 Deb), otoacoustic emissions bilaterally normal. Evoked auditory potentials bilaterally normal (20 Deb). Neurophysicological study in both facial nerves and cranial RMN was normal. Studies to discard neurological, maxillofacial and psychiatrist''s disease were negative or normal. The subject was treated with gabapentin, omeprazol, DIAZEPAM, and metamizol. The patient was discharged on 20 February 2009. On 8 March 2009, the patient was hospitalised for revaluation after several visits to the emergency room with hypoacusia, pain and paresthesia in the right side of the face. The exploration was normal again. It was suspected a possible somatoform disorder (the discomfort sensation stopped repeatedly with placebo). This case was all the information available regarding this case. The regulatory authority will provide additional information if they receive it. Therefore this case was considered closed. Follow up information received on 21 June 2010: On 21 June 2010, GSK has been aware that on a regional TV channel there was a report regarding subject vaccinated with CERVARIX. Laboratory tests have been done in urine hair and stools and showed high levels of Arsenic, Mercury and Nickel. The same analyzes performed in another country were negative. The subject was diagnosed with conversion syndrome or disorder of psychological origin. According to the show, (not medically confirmed), the patient started with dizziness and anxiety crisis and then ear pains. At the time of reporting, the subject still experienced this ear pain, she could not see correctly through the right eye, she could not see correctly through the right eye, she could not move the right arm and both legs. She was in a wheelchair. Further information was not expected and the case remained closed.


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