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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: 509756 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-10-28
Onset:2011-10-28
   Days after vaccination:0
Submitted: 2013-10-25
   Days after onset:728
Entered: 2013-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA146CB / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Convulsion, Dyscalculia, Headache, Hyperventilation, Injection site swelling, Malaise, Memory impairment, Mental impairment, Pyrexia, School refusal
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0933806A

Write-up: This case was reported by a physician via a regulatory authority (V13000717) and described the occurrence of cerebration impaired in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included CERVARIX (GlaxoSmithKline; intramuscular and unknown site of injection) given on 13 September 2011. On 28 October 2011, the subject received 2nd dose of CERVARIX (intramuscular and unknown site of injection). On 28 October 2013, less than one day after vaccination with CERVARIX, the subject experienced injection site swelling. In 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced fever and headache. At an unspecified time after vaccination, the events were resolved. On 31 March 2012 the subject received 3rd dose of CERVARIX (intramuscular, unknown site of injection). In 2012, on an unspecified date after the third vaccination with CERVARIX, the subject presented with injection site swelling, headache and malaise. At an unspecified time after vaccination, headache was resolved. From May 2012, the subject experienced physical deconditioning, headache, school refusal, and hyperventilation attack (hyperpnoea). On 19 September 2013, psychogenic non-epileptic seizure developed. On 7 October 2013, the subject made the first visit to medical centre and short-term memory impairment and dyscalculia were noted. The Regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting, the outcome of the events was unspecified. The regulatory authority reported that the events were related to vaccination with CERVARIX.


VAERS ID: 513979 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-09-11
Onset:2013-09-18
   Days after vaccination:7
Submitted: 2013-11-20
   Days after onset:63
Entered: 2013-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bacterial test negative, CSF white blood cell count increased, Headache, Hypoaesthesia, Mental disorder, Viral infection
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (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, 31 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 09/18/2013, Bacterial test, No bacterial growth; 09/2013, White blood cell count, 200; 09/18/2013, White blood cell count, 80; 10/18/2013, White blood cell count, 50
CDC Split Type: WAES1311HKG004189

Write-up: This spontaneous report as received from a physician via a company sales representative refers to a single, 21 year old patient. The patient had no family history of allergy, history of asthma or concurrent conditions. On 17-JUL-2013, the patient was vaccinated with dose 1 of GARDASIL (lot number and expiry date were not reported). No adverse event was experienced after the first dose of vaccine. The patient had received the second dose of GARDASIL (lot number and expiry date were not reported) on 11-SEP-2013 and came back. Concomitant medications were none. The patient encountered viral infection on an unknown date in 2013. One week after second dose of GARDASIL, on 18-SEP-2013 morning, the patient experienced severe headache, dottiness (for a short while) and whole body numbness. The patient was admitted to hospital on the same day. On 18-SEP-2013, Lumbar puncture sample indicated WBC was 80 (no unit provided), no bacterial growth was observed. The hospital suggested viral infection. Several days later on an unknown date in September 2013, WBC value was 200 (collected by lumbar puncture, no unit provided). One month after hospital admission, on 18-OCT-2013, the WBC value (collected by lumbar puncture, no unit provided) was 50 and patient was discharged from hospital on same day. No symptom or adverse experience was experienced by the patient after discharge. The outcome the events viral infection, severe headache and whole body numbness was reported as resolved (on an unknown date in 2013). The reporter considered all the events to be not related to GARDASIL. Additional information is not expected.


VAERS ID: 516524 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2011-03-01
Onset:0000-00-00
Submitted: 2013-12-13
Entered: 2013-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abnormal behaviour, Activities of daily living impaired, Anxiety, Blood test normal, Depression, Dizziness, Educational problem, Fatigue, Headache, Memory impairment, Mental impairment, Mood swings, Nuclear magnetic resonance imaging normal, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (narrow), Vestibular 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:
Current Illness: Unknown
Preexisting Conditions: Learning disability
Allergies:
Diagnostic Lab Data: Blood test, Normal; Nuclear magnetic resonance imaging, Normal
CDC Split Type: WAES1312IRL005318

Write-up: Information has been received from Sanofi Pasteur MSD (IE-1577272925-E2013-10534) on 11-DEC-2013, as a part of business agreement, via the health authority in a foreign country on 06-Dec-2013. IMB-REF 2013-018966. This case is not medically confirmed as it was reported by a consumer. An adolescent female patient (age not reported), who had special needs as she was previously diagnosed with a mild-moderate general learning disability over the years, received in Dec-2010 a first dose and in Mar-2011 a second dose of GARDASIL (batch number not reported), route and site of administration not reported. After the first dose, over the holiday period since Dec-2010, the patient complained of headaches. It got worse post her second dose of GARDASIL. The patient complained constantly of headaches. Therefore, in 2011, she was not been able to drink, had a dizzy head. Her parents indicated that she could not do the school work she could do before. In 2011, she also suffered serious anxiety, depression, mood swings and her academic and daily functioning was deteriorated. Throughout 2011, she had random bouts of vomiting, she began to present with some very bizarre behaviour and had serious memory impairment. The patient had blood tests done but nothing showed up and a MRI detected nothing at that time. She attended a psychiatrist who put the patient on unspecified medication which according to her parent''s did not help. At the time of reporting, she was on a waiting list to see another neurologist for further testing as the new psychiatrist believed there was something "organic" causing the patient''s problems. Her parents indicated that over the past three years the patient has been tried and tested with various medications that according to them made the patient''s condition worse. At the time of reporting the patient has not recovered from all the adverse events. The IMB considered that case serious due to be medically significant.


VAERS ID: 517964 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-12-20
Onset:2013-12-20
   Days after vaccination:0
Submitted: 2013-12-30
   Days after onset:10
Entered: 2013-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA171AE / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Chest X-ray normal, Immunology test, Insomnia, Measles antibody positive, Mental disorder, Pyrexia, Rash, Rubella antibody negative
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood measles antibody posit, Dec2013, Negative; Chest x-ray, Dec2013, Normal; Enzyme-linked immunosorbent as, Dec2013, Negative; Rubella antibody test, Dec2013, IgG and IgM nega
CDC Split Type: B0955889A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of fever in a 17-year-old female subject who was vaccinated CERVARIX (GlaxoSmithKline). Concurrent medical conditions included drug allergy and osteoarthritis. Concurrent medications included anti-osteoarthritis medicine discontinued 2 days prior the events occurrence. On 20 December 2013, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left arm). On 20 December 2013, less than one day after vaccination with CERVARIX, the subject experienced fever and rash. On 22 December 2013, 2 days after vaccination with CERVARIX, the subject experienced difficulty sleeping and mental disorder. The subject was hospitalised on 22 December 2013. On 24 December 2013, fever and rash were improved. The physician considered fever and rash were probably related to vaccination with CERVARIX.


VAERS ID: 518437 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-03
Entered: 2014-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Decreased appetite, Depression, Disturbance in attention, Headache, Mental impairment, Self injurious behaviour
SMQs:, Suicide/self-injury (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0956767A

Write-up: This case was reported by a healthcare professional (MHLW expert) and described the occurrence of thinking reduced in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of CERVARIX (unknown route, injection site and batch number). Fifteen days after vaccination with CERVARIX, the subject experienced appetite impaired, headache, physical deconditioning, thinking reduced, decreased mental concentration, depression and self-injurious behaviour. The headache persisted for more than 3 months. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified. No further information was provided, the case was closed.


VAERS ID: 523105 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-06-11
Onset:0000-00-00
Submitted: 2014-02-19
Entered: 2014-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Back pain, Decreased interest, Fatigue, Gait disturbance, Grip strength decreased, Guillain-Barre syndrome, Headache, Memory impairment, Mental impairment, Mobility decreased, Neuropathy peripheral, Nuclear magnetic resonance imaging, Orthostatic intolerance, Parosmia, Sluggishness, Somnolence
SMQs:, Peripheral neuropathy (narrow), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Depression (excl suicide and self injury) (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CALONAL; IMIGRAN; METLIGINE
Current Illness: Orthostatic intolerance; Headache
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 03/19/2013, Body temperature, 36.8 degrees; 06/11/2013, Body temperature, 36.9 degrees C; 12/24/2013, Body temperature, 36.6 degrees C
CDC Split Type: WAES1402JPN008216

Write-up: Initial information has been received from a physician via Pharmaceutical and Medical Devices Agency concerning a 14 year old female patient who on 11-JUN-2013 was intramuscularly vaccinated for the second time with GARDASIL injection drug (Lot No.: 9QN08R), 0.5 ml once a day in the upper-third level of the left upper arm of cervix carcinoma. Information including underlying/concomitant diseases and past medical history was not obtained. According to the medical history interview sheet (allergy, underlying disease, status of growth, history of vaccination/disease during recent one month, etc.), the patient had no problem. She had no family history. Other concomitant medications are shown in therapy information. On 19-MAR-2013, the patient''s body temperature was 36.8 degrees Celsius. She was intramuscularly vaccinated with GARDASIL for the first time in the upper-third level of the left upper arm (Lot No.: 9QN08R). There was no concomitant from the patient. On 11-JUN-2013, the patient''s body temperature was 36.9 degrees Celsius. She was intramuscularly vaccinated with GARDASIL for the second time in the upper-third level of the left upper arm (Lot No.: 9QN08R), as stated above. After vaccination, the patient began to fall asleep during meals and also made frequent complaint of headache. The headache persisted for about 2 weeks. The patient somewhat began to lose interest quickly. She took CALONAL and IMIGRAN at times of headache. Also, she was told to have developed orthostatic dysregulation, and was prescribed with METLIGINE to be taken on awakening and at bedtime. In June 2013, the headache that developed after vaccination was diminishing. On an unspecified date (around summer), the patient became unable to walk since she felt that exhaust gases outside smelled extremely bad. On 24-DEC-2013, the patient''s body temperature was 36.6 degrees Celsius. At 4:07 p.m., she was intramuscularly vaccinated with GARDASIL for the third time in the upper-third level of the left upper arm (Lot No.: 9QN12R). At around 6:00 p.m., after returning home, the headache that had been diminishing aggravated. The patient felt pain as if she was being hit on the head with a hammer. She also cold not put strength in both hands, especially in the left hand, so that she dropped her rice bowl. Her gait was abnormal and sluggish. She could run normally and could cross the street before the crossing light changed. At the end of 2013, tears continuously flowed to the lean side when the patient lay down. The patient complained that she was rapidly forgetting what she had learned. She quickly lost interest in her favorite television program and could not watch it continuously. She could not continue taking a meal because both her hands become tired. The patient used to love reading books, but she could no longer recognize the characters. She could not open a milk bottle with her hands or open a plastic bag of bread. On an unspecified date, higher brain dysfunction and Guillain-Barre syndrome developed. On an unspecified date, the patient had MRI taken at the pediatrics department of Hospital A and also visited the department of ophthalmology. On 01-FEB-2014, the patient visited the reporting physician''s hospital with her mother. On 05-FEB-2014, at night, the patient experienced back pan and headache so severe that she could not get up. On 06-FEB-2014, the patient had severe pain in head to the extent that she could not take a painkiller, and slept for more than 18 hours. The patient woke up for a short time at night and took a small amount of meal, and then slept again. She had been absent from school. In February 2014, the patient had no headache with oral painkiller. As of the time of this report, the outcomes of higher brain dysfunction and Guillain-Barre syndrome were not recovered/resolved. The outcomes of orthostatic dysregulation, back pain, sleeping during meals, quick loss of interest, inability to put strength in both hands, abnormal gait, continuous flow of tears to the lean side on laying down, rapid forgetting of learned information, feeling abnormal bad smell of exhaust gasses and peripheral nerve disorder were unknown. Reporter''s comment: The patient was considered to have developed higher brain dysfunction and peripheral nerve dysfunction. The reporting physician considered higher brain dysfunction and Guillain-Barre syndrome as serious due to disability, and did not assess the seriousness of headache, orthostatic dysregulation, Back pain, sleeping during meals, quick loss of interest, inability to put strength in both hands, abnormal gait, continuous flow of tears to the lean side on laying down, rapid forgetting of learned information, feeling abnormal bad smell of exhaust gasses and peripheral nerve disorder. The reporting physician felt that higher brain dysfunction and Guillain-Barre syndrome were related to GARDASIL and considered that there was no other causative factor. The reporting physician did not assess the causal relationship of headache, orthostatic dysregulation, back pain, sleeping during meals, quick loss of interest, inability to put strength in both hands, abnormal gait, continuous flow of tears to the lean side on laying down, rapid forgetting of learned information, feeling abnormal bad smell of exhaust gasses and peripheral nerve disorder to GARDASIL. Additional information has been requested.


VAERS ID: 524178 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-03-08
Onset:2012-08-01
   Days after vaccination:146
Submitted: 2014-02-27
   Days after onset:575
Entered: 2014-02-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA156BA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Albumin CSF increased, Asthenia, CSF protein normal, Cerebral hypoperfusion, Cognitive disorder, Complex partial seizures, Dyslalia, Educational problem, Headache, Malaise, Memory impairment, Mental impairment, Neuropsychological test abnormal, Single photon emission computerised tomogram abnormal, Sleep disorder, Visual field defect
SMQs:, Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Retinal disorders (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Albumin CSF increased, 21.1mg/dl; Cerebrospinal fluid protein, 36mg/dl; Neuropsychological test, See text; Single photon emission compute, Cerebral hypoper; Psychological examination revealed significant decline in language comprehension and working memory.
CDC Split Type: B0971121A

Write-up: This case was reported by a physician via a regulatory authority (# V13001176) and described the occurrence of cerebration impaired in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Historic vaccination included 1st and 2nd doses of CERVARIX (GlaxoSmithKline) given on 1 September 2011 and 5 October 2011 respectively. On 8 March 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). In August 2012, 5 months after vaccination with CERVARIX, the subject''s academic performance was declined. In September 2012, 6 months after vaccination with CERVARIX, the subject had an episode of complex partial seizures starting with visual field defect. In April 2013, 13 months after vaccination with CERVARIX, the subject had headache every day. In November 2013, 20 months after vaccination with CERVARIX, the subject had general malaise. In January 2014, 22 months after vaccination with CERVARIX, the subject had weakness, dyslalia and sleep disorder. On an unspecified date, single-photon emission computed tomography (SPECT) revealed cerebral hypoperfusion, psychological examination showed significant decline in language comprehension and working memory and examination of cerebrospinal fluid showed increased protein (36 mg/dl) and albumin (21.1). The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting, the outcome of the events was unspecified.


VAERS ID: 525250 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-03-01
Onset:2013-05-01
   Days after vaccination:61
Submitted: 2014-03-07
   Days after onset:310
Entered: 2014-03-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA164AA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: CSF cell count normal, CSF protein increased, Dyscalculia, Headache, Hypoaesthesia, Injection site swelling, Menstruation irregular, Mental impairment, Pain, Photophobia, Pruritus, Pyrexia, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Fertility disorders (broad), Hypersensitivity (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Cerebrospinal fluid cell count, Aug2013, Normal; Cerebrospinal fluid protein, Aug2013, Increased
CDC Split Type: B0973361A

Write-up: This case was reported by a physician via a regulatory authority (# V13001197) and described the occurrence of cerebration impaired in a 12-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Historic vaccination included 1st and 2nd doses of CERVARIX (GlaxoSmithKline) given on 2 September 2011 and 12 October 2011 respectively. In March 2013, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site) causing a lengthening of the vaccination schedule. In March 2013, 1 day after vaccination with CERVARIX, the subject experienced injection site swelling. In May 2013, 2 months after vaccination with CERVARIX, the subject experienced headache. In August 2013, the headache worsened. The subject was hospitalised for pyrexia of unknown origin. Cerebrospinal fluid cell count was normal with increased proteins. Thereafter, the subject began to have numbness of upper extremity. As of 25 February 2014, the subject experienced pain, itching, photophobia, dyscalculia, irregular menstruation and sleep disorder. At the time of reporting, the outcome of cerebration impairment and headache were unresolved. The regulatory authority reported that the cerebration impairment was related to vaccination with CERVARIX.


VAERS ID: 526266 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-09-15
Onset:2012-04-01
   Days after vaccination:199
Submitted: 2014-03-20
   Days after onset:718
Entered: 2014-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA145AA / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Educational problem, Gait disturbance, Initial insomnia, Injection site pain, Injection site swelling, Memory impairment, Mental impairment, Muscle twitching, Panic disorder, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0976840A

Write-up: This case was reported by a physician via a regulatory authority (# V13001225) and described the occurrence of cerebration impaired in a 12-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 15 September 2011, the subject received 1st dose of CERVARIX (intramuscular, unknown injection site). Less than one month after vaccination with CERVARIX, the subject experienced marked pain and swelling at the injection site. On an unspecified date, swelling and pain at the injection site were resolved. On 18 October 2011, the subject received 2nd dose of CERVARIX (intramuscular, unknown injection site). Less than 1 year after vaccination with CERVARIX, the subject again experienced marked swelling and pain at the injection site. On 17 March 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). In April 2012, approximately 1 month after vaccination with CERVARIX, tremor and generalized twitching were observed. In November 2012, difficulty in falling asleep was noticed. In May 2013, panic disorder and memory impairment were observed. In January 2014, gait disturbance occurred. In March 2014, academic performance declined. Cerebration impairment was diagnosed. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting, the cerebration impairment was unresolved. The regulatory authority reported that the cerebration impairment was related to vaccination with CERVARIX.


VAERS ID: 526439 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-10-25
Onset:0000-00-00
Submitted: 2014-03-21
Entered: 2014-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA159AA / 2 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Aphasia, Arthralgia, Dizziness postural, Inappropriate schedule of drug administration, Memory impairment, Mental impairment
SMQs:, Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Medication errors (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0976841A

Write-up: This case was reported by a physician via a regulatory authority (# V13001226) and described the occurrence of cerebration impaired in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Historic vaccination included 1st dose of CERVARIX given on 3 May 2011. On 25 October 2011, the subject received 2nd dose of CERVARIX (unknown route and injection site) which led to drug dose administration interval too long. In March 2012, approximately 5 months after vaccination with CERVARIX, the subject experienced dizziness on standing up and arthralgia. On 31 March 2012, the subject received 3rd dose of CERVARIX (unknown route and injection site). In May 2012, arthralgia aggravated. In the autumn of 2012, the subject had memory impairment followed by word-finding difficulty in December 2013. Cerebration impairment was diagnosed. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting, cerebration impairment was unresolved and the outcome of rest of the events was unspecified. The physician considered the cerebration impairment was related to vaccination with CERVARIX.


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https://www.medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=11&SYMPTOMS[]=Mental_disability_%2810027353%29&SYMPTOMS[]=Mental_disorder_%2810061284%29&SYMPTOMS[]=Mental_disorder_due_to_a_general_medical_condition_%2810061285%29&SYMPTOMS[]=Mental_impairment_%2810027374%29&SYMPTOMS[]=Mental_retardation_%2810027378%29&SYMPTOMS[]=Mental_retardation_severity_unspecified_%2810027380%29&SYMPTOMS[]=Mental_status_changes_%2810048294%29&VAX[]=HPV&VAX[]=HPV2&VAX[]=HPV4


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