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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: 409681 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-11-19
Entered: 2010-11-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Mental disorder, Psychotic disorder, Schizophrenia
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives (unspecified)
Current Illness: Smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1011USA01880

Write-up: Information has been received from a healthcare professional (gynecologist) through the Health Authorities on 12-NOV-2010 (reference number PEI2010032643). Case medically confirmed. An approximately 20 years old female patient (smoker) had received a complete series with three doses of GARDASIL (Lot # not reported) on unspecified dates in 2008 (toleration of previous doses of GARDASIL was not reported). "Subsequently", the patient developed psychic disorder with schizophrenia and psychosis leading to hospitalization for an unspecified period. At the time of reporting to HA (24-SEP-2010), the patient had not recovered. Concomitant medication included hormonal contraceptives (unspecified). Further details were not reported so far. Other business partner numbers included E2010-06909. No further information is available.


VAERS ID: 421373 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-03-10
Onset:2011-03-13
   Days after vaccination:3
Submitted: 2011-04-18
   Days after onset:35
Entered: 2011-04-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NK05090 / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Anxiety, Blood pressure systolic increased, Fatigue, Headache, Mental status changes, Nausea, Schellong test, Sinus tachycardia, Syncope, Ultrasound abdomen normal, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives (unspecified), Unk, Unk
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Blood pressure measurement, 16Mar11, $g150 mmHg, systolic; Abdominal ultrasound, 16?Mar11, normal; Orthostatic hypotension measurement, 16?Mar11, normal
CDC Split Type: WAES1104USA01120

Write-up: Information has been received from a pediatrician concerning a 14 year old female patient who on 10-MAR-2011 had received a first dose of GARDASIL (Batch # NN01980; Lot # NK05090) into the left upper arm. Three days later, on 13-MAR-2011, she developed syncope, abdominal pain, nausea, vomiting, headache and tiredness. At the request of the parents, who were worried about reports in the internet, the patient was admitted to a hospital on 16-MAR-2011. Upon admission, the patient was anxious and in a dither. She had sinus tachycardia and increased systolic blood pressure ($g150 mmHg). Laboratory values, abdominal sonography and Schellong test showed normal results. During the further course, blood pressure normalized and the patient complained only of nausea only in the morning. She received corrective treatment with MAALOXAN (to be reduced after discharge). In case of persistent nausea, gastroscopy was recommended by the hospital physicians. On 18-MAR-2011, the patient was discharged, completely recovered. Concomitant medication included hormonal contraceptives (unspecified). Regarding the causality assessment, the reporter crossed both "possible" and "unlikely". The case was medically confirmed. Other business partner numbers include: E2011-02199. This case is closed. No further information is available.


VAERS ID: 421933 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-04-05
Onset:2011-04-05
   Days after vaccination:0
Submitted: 2011-04-28
   Days after onset:23
Entered: 2011-04-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Application site erythema, Hypersensitivity, Malaise, Mental disorder
SMQs:, Angioedema (broad), Dementia (broad), Hypersensitivity (narrow), 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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ZYRTEC
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1104USA00598

Write-up: Information has been received from a physician (local reference # CZE11077) concerning a female patient who on unknown date, was vaccinated with a first dose of GARDASIL (lot number, dose and site of administration not reported). The patient was very nervous and frightened during the vaccination. On 05-APR-2011 "after the administration" the patient had an erythema in the application site. Also, it was reported that during the night the patient was not feeling well and her parents took her to the hospital and the patient was hospitalized. The physician reported that the patient is mentally instable. ZYRTEC was given for local "possible" allergic reaction. Follow up information has been received from a physician concerning a patient who on 05-APR-2011, was vaccinated with a first dose of GARDASIL (dose and site of administration not reported). The patient was hospitalized from 05-APR-2011 till 06-APR-2011. It was reported that the stop dates for the adverse experiences of erythema at the application site and allergic reaction was on 06-APR-2011. At the time of the report, the patient''s outcome was unknown. No further information is available.


VAERS ID: 425771 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-04-17
Onset:2011-04-30
   Days after vaccination:13
Submitted: 2011-06-20
   Days after onset:51
Entered: 2011-06-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NK44350 / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS A06FC376A / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Decreased appetite, Herpes zoster, Mental disorder, Ophthalmological examination, Paraesthesia, Pyrexia, Rash, Viral test positive
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Diagnostic laboratory test, 15May11, Blood sample: an infected area indicated a virus (no further specified).
CDC Split Type: WAES1106USA01849

Write-up: Case received from a consumer via the Health Authorities on 08-JUN-2011, under the reference number: DK-DKMA-ADR21087197. Case not medically confirmed. An 11 year old female patient received an injection of GARDASIL (lot number: NK44350; batch number: NN02290) as well as a PRIORIX (batch number: A06FC376A/A69DC376A) on 17-APR-2011 and later on 30-APR-2011, the patient developed fever and decreased appetite. On 15-MAY-2011, the patient also developed herpes zoster. The patient had fever for 3 days. A doctor took a blood sample and an infected area indicated a virus (no further specified). On 10-MAY-2011, the patient complained over a tingling sensation of left arm and left shoulder/back and on 15-MAY-2011, she was diagnosed with herpes zoster. During the episode, the patient had had decreased appetite and had been mentally affected by the situation. The patient was admitted to a pediatric hospital where she was isolated for 5 hours (date not reported). A blood sample was taken (no result provided); her eyes and the rash were examinated during the visit. The rash was improving. The last day of progress was around 22-MAY-2011. Upon medical review, the company judged relevant to code the following adverse events: tingling sensation and mentally affected which were mentioned by the Health Authority in the narrative but not coded. At the time of reporting, the outcome of fever was recovered, for herpes zoster it was recovering (also reported as unknown) and unknown for decrease appetite. No causality was provided. Corrective version created on 15-JUN-2011: Tingling sensation was not coded by the company as mentioned in the initial narrative. Other business partner number included: E2011-03537. No further information is available.


VAERS ID: 434057 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-01-12
Onset:2011-03-15
   Days after vaccination:62
Submitted: 2011-09-09
   Days after onset:178
Entered: 2011-09-12
   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: Abasia, Dyskinesia, Erythema, Gait disturbance, Mental disorder, Neurological examination normal, Nuclear magnetic resonance imaging normal, Pain in extremity, Scan normal, Wheelchair user
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (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? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: diagnostic laboratory test, 24Mar11, Scan: normal; neurological examination, 06Apr11, normal; magnetic resonance imaging, 02May11, MRI of the spine and the bone marrow: strictly normal
CDC Split Type: WAES1109USA00248

Write-up: Case received from a physician on 29-AUG-2011. Case medically confirmed. A 14-year-old female patient had received a first dose of GARDASIL (batch number not reported) on 12-JAN-2011. She developed gait disorders 2 months after vaccination and severe pains in the soles of the feet on an unspecified time to onset. On 15-MAR-2011, more than 2 months after vaccination she experienced uncontrollable movements of her head and trunk without loss of consciousness. The patient was seen by her physician shortly afterwards. Medical examination was normal but her physician decided to admit her to a paediatric emergency department as a precautionary measure. The patient was discharged quickly and those disorders were classified as ''psychological phenomena''. Nonetheless, on 18-MAR-2011, the patient was seen by her physician once again as she had developed gait disorders (like she was suffering from equinovirus deformity). On 24-MAR-2011 a scan was performed and was normal. The patient visited an osteopath on 25-MAR-2011. Consecutively psychological examination was performed. Her symptoms worsened and were accompanied by severe pains in the soles of the feet with mild erythema in this area. On 06-APR-2011 neurological examination was performed and was normal. At the end of April in 2011, the patient was unable to walk and was using a wheelchair. At that time the patient was hospitalised in a functional and physical rehabilitation center in order to prevent muscle weakness. On 02-MAY-2011, a MRI (magnetic resonance imaging) of the spine and the bone marrow was performed and was strictly normal. The patient fully recovered after a 3-week stay in the center. On 08-AUG-2011, she was seen again by her physician who noticed no sequelae. To be noted that on 25-MAR-2011, i.e. 10 days after the onset of the symptoms, the patient received a second dose of GARDASIL (batch number not reported). According to her neurologist, there was no causal relationship between the reported reactions and vaccination. Other business partner numbers include E2011-05246. No further information is available.


VAERS ID: 437139 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-09-25
Onset:2011-09-25
   Days after vaccination:0
Submitted: 2011-10-06
   Days after onset:11
Entered: 2011-10-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1336Z / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arrhythmia, Condition aggravated, Immediate post-injection reaction, Loss of consciousness, Mental impairment, Pallor, Pulse pressure decreased, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (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? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Loss of consciousness; Heat illness
Allergies:
Diagnostic Lab Data: blood pressure measurement, 25Sep11, 90 mmHg, Systolic (At 12:05 before inoculation); blood pressure measurement, 25Sep11, 64 mmHg, Diastolic (At 12:05 before inoculation); blood pressure measurement, 25Sep11, 118 mmHg, Systolic (Approximately 1 minute later); blood pressure measurement, 25Sep11, 70 mmHg, Diastolic (Approximately 1 minute later); blood pressure measurement, 25Sep11, 98 mmHg, Systolic (2 minutes later); blood pressure measurement, 25Sep11, 58 mmHg, Diastolic (2 minutes later); blood pressure measurement, 25Sep11, 54 mmHg, Diastolic (At 12:55); blood pressure measurement, 25Sep11, 108 mmHg, Systolic (At 12:55); body temp, 25Sep11, 36.4 degrees C, At 12:05 before inoculation; total heartbeat count, 25Sep11, 70 /min, At 12:05 before inoculation; total heartbeat count, 25Sep11, 70 /min, At 12:55; total heartbeat count, 25Sep11, 60 /min, 2 minutes later; total heartbeat count, 25Sep11, 70 /min, Approximately 1 minute later
CDC Split Type: WAES1110USA00022

Write-up: Information has been received from a physician concerning a 14 year and 3 month old female patient with a history of consciousness loss attack following influenza vaccine (November 2008) and consciousness loss attack at the time of heat illness (September 2010) who on 25-SEP-2011 (12:05) was vaccinated with the first dose of GARDASIL (lot number 1336Z, batch number 9QN01R), 0.5 mL, intramuscularly into left upper arm. No other vaccine was injected at the same time. No information on concomitant medications had been provided. On 25-SEP-2011, before inoculation of the vaccine, her body temperature was 36.4 degrees C, blood pressure 90/64 and pulse was 70/regular, (12:05), the physician asked the patient "would you like to lie down for injection?" and the patient commented "this time seems fine", therefore the patient received the vaccine in a sitting position. Immediately after injection the vaccine (approximately 30 seconds), when the patient turned to her mother, the patient collapsed forward from the chair. She had loss of consciousness and arrhythmia. Pulse pressure was weak and she was immediately placed in a recumbent position with both legs up. Approximately 1 minute later, her consciousness returned, blood pressure was 118/70, pulse was 70/regular and she had facial pallor. Thereafter, her condition was stabilized and she stayed in a sitting position, however, 2 minutes later, she returned to a recumbent position due to severe dullness. Blood pressure was 98/58 and pulse was 60/regular. Starting medium (1) (SOLITA-T No.1) 200 mL was administered via intravenous drip infusion. At 12:55, blood pressure was 108/54 and pulse was 70/regular. She had no problem holding standing position and went home. During the course, there was no measurement of blood glucose, ammonia and ethanol levels. The reporting physician considered that loss of consciousness was serious as other important medical event. The reporting physician considered that loss of consciousness was serious as other important medical event. The reporting physician felt that loss of consciousness was definitely related to GARDASIL and there was no other factor. No further information is available.


VAERS ID: 452551 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-01-16
Onset:2012-01-16
   Days after vaccination:0
Submitted: 2012-03-27
   Days after onset:70
Entered: 2012-03-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Amnesia, Depressed mood, Mental disorder
SMQs:, Dementia (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (narrow)

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? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1203USA02614

Write-up: Case received from a gynecologist on 19-MAR-2012 via the contractual partner under the reference number SPV12004. Case medically confirmed. The reporting physician was distressed when the parents informed him of the event and assessed the case as serious. A 18-year-old female patient had received the second dose of GARDASIL, via intramuscular route on 16-Jan-2012 (dose and lot number not reported), and two hours post-vaccination she developed depressed mood and partial memory loss for 5 days. The patient was not taking any concomitant medication at the time of vaccination. The symptoms resolved without treatment and without any psychological intervention. The reporting physician diagnosed a mild psychological disorder possibly related to the vaccination. It is worth noting that the patient had received the first dose of GARDASIL on 09-NOV-2011 and that she had a free medical history, with no family history of allergies. At the time of reporting, the patient had recovered. Mild psychological disorder, partial memory loss and depressed mood were considered to be an other important medical event by the reporter. Other business partner numbers include E2012-01887. No further information is available.


VAERS ID: 455981 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-03-19
Onset:2012-03-19
   Days after vaccination:0
Submitted: 2012-05-21
   Days after onset:63
Entered: 2012-05-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NN12610 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Clonus, Dysstasia, Feeling cold, Laboratory test normal, Mental disorder, Muscle spasms
SMQs:, Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Panic attack
Allergies:
Diagnostic Lab Data: Blood pressure measurement, 19Mar12, within normal range; Diagnostic laboratory test, within normal limits
CDC Split Type: WAES1205USA02549

Write-up: Information has been received from Health Authority (case n. 16604) (local case n. IT219/12). Initial report received on 10-MAY-2012 and additional information on 11-MAY-2012. Case medically confirmed. A 14 year old female patient was vaccinated on 19-MAR-2012 with the first dose of GARDASIL (dose and route not reported) (lot number NN12610, batch number G006099). From December 2010 to June 2011 the patient was being treated with RISPERDAL because of panic attacks. On the same day, 2-3 minutes post-vaccination, she was unable to maintain the standing position, she referred being cold and she presented with brief clonus particularly of the upper limbs and facial muscle spasms always of brief duration. The patient arterial blood pressure remained within normal range and there was no loss of consciousness. The patient was taken to the ER and hospitalized. All lab and investigations performed (NOS) were within normal limits. Currently the patient is under psychiatric and psychological care. According to the hospital physician, the vaccination may had triggered a significant psychiatric reaction in a susceptible patient. At the time of the reporting the patient had not yet recovered. The final outcome was not reported. Upon medical review the Company judged relevant to code the adverse events "clonus" and "psychiatric reaction" which were mentioned in the narrative but not coded by HA. The case is closed. Other business partner numbers include E2012-03052. No further information is available.


VAERS ID: 467209 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-04-01
Onset:2012-04-01
   Days after vaccination:0
Submitted: 2012-10-02
   Days after onset:184
Entered: 2012-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Affective disorder, Amnesia, Dissociative disorder, Dizziness, Dyskinesia, Hallucination, visual, Headache, Mental disorder, Nuclear magnetic resonance imaging brain normal, Personality disorder
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (narrow), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Nuclear magnetic resonance ima, 2012, no abnormality
CDC Split Type: B0834108A

Write-up: This case was reported by a physician via a regulatory authority and described the occurrence of psychiatric disorders in a 17-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In April 2012, the subject received 1st dose of CERVARIX (unknown route and site of injection, batch number not provided). In April 2012, some hours after vaccination with CERVARIX, the subject experienced psychiatric disorders, visual hallucinations, abnormal movements amnesia, headache, dizziness, mood disorders, dissociative symptoms and personality disorders. The subject was hospitalised. A magnetic resonance did not show any abnormality. The subject was treated with benzodiazepines, haloperidol and sertraline. Psychiatric disorders improved after haloperidol treatment. At the time of reporting the events were improved. The regulatory authority reported that the events were possibly related to vaccination with CERVARIX.


VAERS ID: 475211 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-03-11
Onset:2008-06-15
   Days after vaccination:96
Submitted: 2012-11-21
   Days after onset:1620
Entered: 2012-11-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Biopsy brain abnormal, CSF cell count increased, CSF culture positive, Cognitive disorder, Convulsion, Disturbance in attention, Emotional disorder, Epilepsy, Mental disorder, Mental disorder due to a general medical condition, Nervous system disorder, 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), Depression (excl suicide and self injury) (broad), 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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 26-AUG-2012: brain biopsy: reactive astrocytic gliosis; Date unknown: number of cerebrospinal fluid cells increased; CSF culture, Increased
CDC Split Type: WAES1211FRA007542

Write-up: Case received from the Health Authorities in a foreign country on 15-Jan-2009 under the reference number PEI2008021098. It was reported by a neurologist that a 17-year-old female patient was vaccinated with a third dose of GARDASIL (lot no., injection site not reported) IM on 11-Mar-2008. Starting mid-Jun-2008, the patient developed cerebral vasculitis with acute psychotic symptoms and seizures. Cerebral biopsy, performed on 26-Aug-2008, revealed reactive astrocytic gliosis. Lab findings 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. D1 GARDASIL was given on 18-Sep-07, D2 GARDASIL was given on 20-Nov-07. Toleration was not reported. Follow-up information received on 06-Oct-2009. A statement of the neurological hospital was sent. The statement was made by a member of the drug committee of the medical fraternity. The patient''s mother had a medical history of multiple sclerosis. The patient showed first psychical abnormalities in Jun-2008. She experienced severe organic brain syndrome with slowdown, impaired concentration, neuropsychological disorder with symptomatic psychosis and symptomatic epilepsy. Suspicion of isolated cerebral vasculitis was diagnosed. The diagnosis of isolated cerebral vasculitis was based on different imaging investigations and clinical investigations, CSF diagnostics, angiography and leptomeningeal biopsy. Under therapy with cortisone, neuroleptics and antiepileptics the symptoms slowly improved. He stated that despite the long latency (3 months) the vaccine as cause could not be ruled out and assessed the relation to the vaccine as possible. File closed. Case was retrieved from the literature on 09-Nov-2012. The publication doe snot contain new medical information on this case. CASE IS CLOSED. Upon internal review, it was noted that the country of incidence was incorrectly entered for MARRS # 0901USA02687. Therefore, MARRS # 0901USA02687 is being deleted from our files and replaced by MARRS # 1211FRA007542 with the correct country of incidence.


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