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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: 578325 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-03-12
Onset:2015-03-12
   Days after vaccination:0
Submitted: 2015-05-08
   Days after onset:57
Entered: 2015-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K004961 / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Hyperhidrosis, Mental status changes, Pallor, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1505AUS001702

Write-up: Information was obtained on a request by the Company from the Agency via Public Case Detail (# 356275) concerning a 13 year old male patient. On 12-MAR-2015, the patient received dose 1 of GARDASIL (lot # K004961, expiry date: not provided) intramuscular injection in the left arm. On the same day at 13:55 hours after onset of therapy the patient experienced changed level of consciousness. At 14:00 hours, adrenaline was given for the event which caused a dramatic improvement. After that, the patient began to shake. He was pale and sweaty and stated that he was unable to breathe. Outcome of the events were reported as recovered. Reporting agency considered all the events to be possibly related to GARDASIL. Reporting agency considered the events to be serious. Additional information is not expected as no further information can be obtained from the local regulatory authority.


VAERS ID: 578410 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-28
Onset:0000-00-00
Submitted: 2015-05-12
Entered: 2015-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0773X / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Computerised tomogram head normal, Cystitis, Dysstasia, Fatigue, Impaired work ability, Memory impairment, Mental disorder, Pneumonia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

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: Speech disorder; Lethargy; Fatigue; Learning disorder; 2005, Mental disorder; 1996, Asthma; UV light therapy; Continuous positive airway pressure; 1994, Premature baby
Allergies:
Diagnostic Lab Data: CT brain scan (Unknown Date): Nothing abnormal
CDC Split Type: WAES1505DNK002956

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (Case report N. DK-1577272925-E2015-04654) on 07-MAY-2015. Case received from a consumer or other non health professional via the Health Authorities on 05-May-2015 under the reference number DK-DKMA-ADR 2296217. Case is not medically confirmed. A 14-year-old female patient (weight and height not reported) had received the first injection of Gardasil, batch number NJ01850, lot number 1941U, expiration date: 12-DEC-2010 via intramuscular route into a not reported site of administration on 16-Feb-2009, the second injection of GARDASIL, batch number reported as NJ53800 via intramuscular route into a not reported site of administration on 15-Apr-2009 and the third injection of GARDASIL, batch NK05560, lot number 0773X, expiration date: 16-JUN-2011 via intramuscular route into a not reported site of administration on 28-Oct-2009. The patient''s medical history included born premature: P3, premature, CRAP-treated (presumably typing error of CPAP), light therapy due to icterus. The patient had asthma in 1996, psychological (2005). Until 2005 normal development was seen. She had during the last period fallen behind in terms of learning. She had to repeat nursery school due to tiredness, was lethargic. She was assigned to the pedagogical psychological advise (PPR) with both psychologist and speech therapist. It had been discussed about left side dominance and possibly may be a condition of her birth and neonatal period. Approximately two months after vaccination, in 2009, the patient became tired and weak. On an unspecified date in 2013, the patient developed memory impaired, shaking, difficulty in standing and on a not reported date cystitis and pneumonia. Cranial computed tomography showed nothing abnormal - one assumed that the were psychological reasons for the patient''s problems. Other medication: no. At the time of reporting, the outcome of the events were unknown. Upon internal review the company judged relevant to code "psychological disorder" which was mentioned by the HA in the narrative but not coded. Comment: "The family has seen the broadcast about HPV on TV and wishes that the physician reports the patient''s problems as vaccine adverse reactions. On sick leave for almost 1 year (2010). The family received the information that the cause was asthma/or psychological problems. Comments: This case is not medically confirmed, as the physician does not believe that it is a case of adverse reactions to GARDASIL."


VAERS ID: 578638 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-04-28
Submitted: 2015-05-15
   Days after onset:382
Entered: 2015-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Acne, Anxiety, Asthenia, Back pain, Chest pain, Computerised tomogram, Computerised tomogram normal, Depressed mood, Dizziness, Dysmenorrhoea, Electroencephalogram normal, Eye pain, Fatigue, Haemorrhage subcutaneous, Headache, Hypoaesthesia, Insomnia, Lumbar puncture normal, Lymph node pain, Mental disorder, Mood swings, Muscle spasms, Myalgia, Nausea, Neck pain, Nightmare, Nuclear magnetic resonance imaging normal, Pain, Pain in jaw, Panic attack, Paraesthesia, Regressive behaviour, Viral test negative, Vision blurred, Vitamin D, X-ray dental normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Computerised tomogram, no findings; Electroencephalogram, no findings; Lumbar puncture, no findings; Nuclear magnetic resonance imaging, no findings; Vitamin D deficiency, no findings; X-ray, jaw: no findings
CDC Split Type: WAES1505DNK005883

Write-up: Information was received from Sanofi Pasteur MSD (DK-1577272925-E2015-04999) on 13-MAY-2015. Case received from a consumer or other non health professional via the Health Authorities on 08-MAY-2015 under the reference number DK-DKMA-ADR 22969478 and DK-DKMA-EFO11817. Case is not medically confirmed. A 12-year-old female patient (weight 64 kg, height 167 cm) with no medical history reported, had received a doses of GARDASIL, (batch number not reported) via intramuscular route into not reported site of administration on an unspecified date. On 28-APR-2014, the patient developed dizziness, depressed mood, unresponsive violent cramp attacks, cramp attacks, nausea and energy decreased. On 01-MAY-2014, the patient experienced chronic tiredness, mood swings, severe muscle pain, abdominal pain, lymph node pain (often on both sides of the throat lymphs), sleeplessness, severe nightmares, headache, pain in the entire body (especially neck and back), blood blastings in several places on the skin, large pimples on the back (impure skin), the body bones creak (breaks once she breaths) and small buds on the arm and back. On an unspecified date in October-2014, the patient experienced severe menstrual pain. The patient developed stinging chest pain and pain in the front on 01-JAN-2015, vision was blurred/wandering and stinging pain back at the eyes on 30-JAN-2015, tingling numb fingers on 01-FEB-2015, panic anxiety attack on 01-MAR-2015 and jaw pain on 01-APR-2015. The patient had been hospitalized several times in the department and received a lot of tests: EEG, MRI scan, lumbar puncture, CT Scanning, ears, Hormonal/diabetes, viruses on the balance nerve, vitamin D deficiency. Examined by dental care, x-ray jaw. Examined all physicals without finding answers, therefore it had to be mental, turned over to Psychiatric where she was offered talks and the parents could discuss. Had now been there many times and did not progress on. It was reported by the parents that it had not been psychic because they knew their daughter best. The patient exercised martial arts 2 times a week, was in good shape, but had regressed a lot physically. At the time of reporting, the patient was recovering from abdominal pain and stinging chest pain but had not recovered from all the other events.


VAERS ID: 578705 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2014-02-01
Onset:0000-00-00
Submitted: 2015-05-18
Entered: 2015-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Decreased appetite, Gait disturbance, Hyperkinesia, Mental impairment, Movement disorder, Psychomotor hyperactivity, Ulna fracture, Weight decreased
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Autism spectrum disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN065153

Write-up: This case was reported by a physician via sales rep and described the occurrence of hyperkinesis in a female subject who received CERVARIX. Concurrent medical conditions included pervasive developmental disorder. In August 2013, the subject received CERVARIX (intramuscular). In February 2014, the dose was an unknown dose. In February 2014, unknown after receiving CERVARIX, the subject experienced appetite impaired (serious criteria other), gait disturbance (serious criteria other), movement disorder (serious criteria other), weight decreased (serious criteria other), ulna fracture (serious criteria other) and intelligence decreased (serious criteria GSK medically significant and other). On an unknown date, the subject experienced hyperkinesis (serious criteria hospitalization) and hyperactivity (serious criteria hospitalization). On an unknown date, the outcome of the hyperkinesis, hyperactivity, appetite impaired gait disturbance, movement disorder, weight decreased, ulna fracture and intelligence decreased were unknown. It was unknown if the reporter considered the hyperkinesis hyperactivity, appetite impaired, gait disturbance, movement disorder, weight decreased, ulna fracture and intelligence decreased to be related to CERVARIX. The symptoms developed, and the subject became able to move her body after taking Goou. Subsequently, hyperkinesis and hyperactivity developed, for which the subject was hospitalised.


VAERS ID: 578892 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-09-23
Onset:2014-09-23
   Days after vaccination:0
Submitted: 2015-05-20
   Days after onset:239
Entered: 2015-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K002433 / 2 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Headache, Mental status changes, Vaccination site pain, Vomiting
SMQs:, Acute pancreatitis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1505BRA008177

Write-up: This spontaneous report was received from a consumer (also reported as patient''s mother) via institute (business partner reference number not provided) refers to a 14 year old female patient. It was reported that the patient was not a pregnant. There was no medical history reported. On an unknown date patient was vaccinated with first dose of GARDASIL (strength 0.5 ml) (lot number and expiry date unknown) intramuscular injection (0.5 ml, frequency unknown). On 23-SEP-2014 the patient was vaccinated with second dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. Vaccine, 0.5 ml via intramuscular route in the right deltoids (Lot number reported as K002433, expiry date unknown). No concomitant medications were reported. On 23-SEP-2014, the patient experienced Tonic convulsion without fever (medically significant), pain at vaccination site for 2 hours, headache lasting 30 minutes, vomiting and consciousness level changes. The patient was hospitalized on 25-SEP-2014 for all the events. The hospital discharge information was not available. The action taken with the therapy with quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. Vaccine was unknown. The patient did not recover from the adverse events (also reported as recovered). The relatedness for the events to quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. Vaccine was unknown. The reporter considered the event tonic convulsion without fever to be medically significant and hospitalisation. Additional information is not expected as reporter could not provide patient''s physician contact details.


VAERS ID: 578940 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-03-01
Onset:2014-05-01
   Days after vaccination:791
Submitted: 2015-05-20
   Days after onset:384
Entered: 2015-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cerebral atrophy, Cognitive disorder, Encephalitis, Headache, Malaise, Mental impairment, Nuclear magnetic resonance imaging brain abnormal
SMQs:, Dementia (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN067722

Write-up: This case was reported by a consumer and described the occurrence of circumscribed cerebral atrophy in a 18-year-old female subject who received CERVARIX. In September 2011, the subject received the 1st dose of CERVARIX (intramuscular). On an unknown date, the 2nd dose was an unknown dose. In March 2012, the 3rd dose was an unknown dose. In May 2014, unknown after receiving CERVARIX, the subject experienced cerebration impaired (serious criteria GSK medically significant). On an unknown date, the subject experienced circumscribed cerebral atrophy (serious criteria GSK medically significant), encephalitis (serious criteria GSK medically significant), headache, malaise and cognitive disorder. On an unknown date, the outcome of the circumscribed cerebral atrophy, encephalitis, cerebration impaired, headache, malaise and cognitive disorder were unknown. It was not reported if the reporter considered the circumscribed cerebral atrophy, encephalitis, cerebration impaired, headache, malaise and cognitive disorder to be related to CERVARIX. It was unknown whether the product was a GSK-manufactured product or not. On an unknown date, the subject received the second dose of CERVARIX (intramuscular). Shortly after the administration of the second dose, the subject developed headache and malaise. In December 2013, the subject underwent examinations including a magnetic resonance imaging (MRI), which showed hippocampal atrophy, and suspected limbic encephalitis was diagnosed. In May 2015, the subject developed symptoms suggestive of higher brain dysfunction. The subject cannot remember the location of the bathroom as well as her brother''s name. At meals, the subject was not able to figure out the names of the foods as well as how to eat them. The subject returned to her former state after about 10 days this time, but the similar symptoms developed half a year later. At the time or reporting, the subject was taking approximately 20 different supplements each day, and also has been going to see a masseuse once a week.


VAERS ID: 578941 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-05-01
Onset:2013-05-01
   Days after vaccination:0
Submitted: 2015-05-20
   Days after onset:749
Entered: 2015-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Amnesia, Cognitive disorder, Headache, Intelligence test abnormal, Loss of consciousness, Memory impairment, Mental impairment
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), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: May 2014: Intelligence quotient of 22.
CDC Split Type: JP2015JPN067736

Write-up: This case was reported by a consumer and described the occurrence of cognitive disorder in a 17-year-old female subject who received CERVARIX. In May 2013, the subject received the 1st dose of CERVARIX (intramuscular). In May 2013, unknown after receiving CERVARIX, the subject experienced headache. In June 2013, the subject experienced amnesia. On an unknown date, the subject experienced cognitive disorder (serious criteria disability), intelligence decreased (serious criteria GSK medically significant) and loss of consciousness (serious criteria GSK medically significant). On an unknown date, the outcome of the cognitive disorder, intelligence decreased, loss of consciousness, headache and amnesia were unknown. It was not reported if the reporter considered the cognitive disorder, intelligence decreased, loss of consciousness, headache and amnesia to be related to CERVARIX. It was unknown whether or not the product was a GSK a product. The subject started suffering from the events including headache immediately after the first vaccination. After June 2013, forgetfulness worsened. The subject''s condition was instantly aggravated. In May 2014, based on the results of examinations, the subject was certified as the first grade intellectual disability with intelligence quotient of 22. Since the severity of symptoms varied greatly, the subject somehow managed to attend high school as there are times when the was able to have a normal conversation. The subject became unable to recognize her mother and forgotten her friends'' faces since unknown time. The subject had recently been experiencing the repeated loss consciousness. Results of relevant tests and procedures associated with the diagnosis: May 2014: Intelligence quotient of 22.


VAERS ID: 582142 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-10-09
Onset:0000-00-00
Submitted: 2015-06-12
Entered: 2015-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA162CA / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Autonomic nervous system imbalance, Cognitive disorder, Headache, Illusion, Mental impairment, Nervous system disorder, Nuclear magnetic resonance imaging brain normal, Stress
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN070917

Write-up: This case was reported in a literature article and described the occurrence of mental deterioration in a female subject who received CERVARIX. On 30th July 2012, the subject received the 1st dose of CERVARIX (intramuscular). On 9th October 2012, the 2nd dose was an unknown dose. On an unknown date, unknown after receiving CERVARIX, the subject experienced mental deterioration (serious criteria GSK medically significant), perceptual disturbance, cognitive disorder, autonomic dysfunction, headache, anxiety and central nervous system disorder. On an unknown date, the outcome of the mental deterioration, perceptual disturbance, cognitive disorder, autonomic dysfunction, headache, anxiety and central nervous system disorder were unknown. It was not reported if the reporter considered the mental deterioration, perceptual disturbance, cognitive disorder, autonomic dysfunction, headache, anxiety and central nervous system disorder to be related to CERVARIX. The symptoms had worsened from 2 months to 1 year and 9 months after the onset. During the clinical course, headache and central nerve symptoms developed in a variety of combinations. The symptoms worsened due to stress including anxiety. Results of relevant tests and procedures associated with the diagnosis. On an unknown date: Magnetic resonance imaging (MRI) brain: No abnormality was noted. Among the studied 4 cases (3 cased with CERVARIX, 1 case with GARDASIL), abnormal findings of neuropsychology and single photon emission computed tomography (SPECT) or glutamate receptor antibodies (GluR) in cerebrospinal fluid were confirmed, and therefore, the possibility that immunological abnormality may have resulted in central nerve disorder was considered. Although no treatment approach has yet been established, environmental adjustment for anxiety was considered to be important. When headache and various central nerve symptoms are noted after human papillomavirus (HPV) vaccination, further examinations included neuropsychology, SPECT, and cerebrospinal fluid GluR should be recommended.


VAERS ID: 583808 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-06-24
Entered: 2015-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Arthritis, Autonomic nervous system imbalance, Complex regional pain syndrome, Crying, Dizziness postural, Gait inability, Headache, Learning disorder, Malaise, Mental impairment, Movement disorder, Orthostatic hypotension, Orthostatic intolerance, Pain, Postural orthostatic tachycardia syndrome, School refusal, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Arthritis (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN087537

Write-up: This case was reported via a study protocol that was applied for GSK. The symptoms below were noted among the subjects who received CERVARIX or GARDASIL age between 13 and 36 years who were consulted between June 2013 and May 2015. Cerebration impaired (serious criteria GSK medically significant), headache, general malaise, pain, tremulousness, autonomic nervous system imbalance, orthostatic dysregulation, complex regional pain syndrome, learning disorder, hypersomnia, sleep disorder, dizziness on standing up, movement disorder, arthralgia, arthritis, abasia (serious criteria GSK medically significant), school refusal, crying, postural orthostatic tachycardia syndrome and orthostatic hypotension.


VAERS ID: 583815 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-09-20
Onset:2012-09-20
   Days after vaccination:0
Submitted: 2015-06-24
   Days after onset:1007
Entered: 2015-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H008259 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Asthenia, Chronic fatigue syndrome, Depression, Distractibility, Disturbance in attention, Dizziness, Dyskinesia, Dyspnoea, Exercise tolerance decreased, Fatigue, Gait disturbance, Headache, Immobile, Loss of personal independence in daily activities, Malaise, Mental disorder, Myalgia, Nausea, Neurological examination normal, Nuclear magnetic resonance imaging normal, Pain, Pallor, Pharyngitis streptococcal, Psychiatric evaluation, Pyrexia, Seizure, Somnolence, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Parkinson-like events (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: MRI: No abnormality detected (normal)
CDC Split Type: WAES1506IRL011343

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) [Manufacturer Control Number IE-1577272925-E2015-06980] on 22-JUN-2015. This case was received from the health authority on 18-Jun-2015. Ref IE-HPRA-2015-023788. This case is medically confirmed. A 12 year old female patient who was previously healthy and well received dose one of GARDASIL, batch/lot number H008259, expiry date reported as 31-Jan-2015, route and site not reported, on 20-Sep-2012. Post vaccination the patient experienced chronic fatigue syndrome. The patient''s father stated that immediately after the vaccine the patient felt dizzy and sick. A few days post vaccination, the patient developed weakness and loss of power after taking part in sports. He also stated that the patient experienced immobility, pains, seizures, headaches, nausea, abdominal pains and eyesight deterioration. The patient subsequently developed depression. The patient could initially only attend school 2 - 2.5 days a week and later not at all. She was later diagnosed with chronic fatigue syndrome. The patient''s power returned but not fully. In Nov/2014, the patient deteriorated and developed psychological problems and has been an in-patient at a children''s unit of a mental hospital since 23/Jan/2015. A community care doctor stated the following: Three days post vaccination with her first dose of GARDASIL the patient went to a sporting event and became unwell. The patient''s father indicated that the patient complained of being nauseous, feeling sick, weak and she looked quiet pale. The patient sat beside her father and fell asleep at the event during the day which was unusual for her. The patient''s father indicated that they decided to leave the event early but the patient was unable to walk at her normal pace to the train. During the short train journey, the patient fell asleep again. On exiting the train, the patient felt even weaker and felt she was going to collapse. Eventually the patient''s father had to carry her for the remainder of their journey to a relatives house where the patient appeared to have difficulty breathing. The patient''s father indicated that the patient looked like she was having an asthma attack but does not suffer from asthma. She also had jerking movement of her arms, legs and body. The patient was seen by a GP in the area that day and told the patient''s father that the patient had a fever and appeared to have a Strep sore throat. He gave the patient an unspecified treatment at the house which improved some of her symptoms and provided a letter for hospital admission. The jerking movements of her arms and legs continued on and off and the following day, when they drove home. The jerking movements appeared to be increasing in frequency and they were seen by the family GP who also referred her to hospital for admission. At hospital unspecified tests were carried out. The patient''s symptoms improved over the next few days however, she remained weak and complained of intermittent muscle pain in her limbs. Her gait was altered because of her weak muscles and pain. The hospital doctor referred the patient to a Neurologist for further evaluation where no neurological abnormality was detected in the patient. The patient''s parents also spoke to the doctor who was in charge of administering school vaccines in the area and the patient was re-admitted to hospital for further investigation in Oct 2012. An MRI scan was carried out and no abnormality was detected. The hospital doctor referred the patient to a Clinical Psychologist. Over the next month improvement was slow and the patient was not back to herself. The patient''s parents decided to change her to the local school to complete her studies. However, due to physical exhaustion she was only able to attend 2-3 days per week. The patient''s parents noticed at that point that she had become insecure in herself. In 2012 she began to attend school more frequently at 4 days per week and by Apr-2013 she was pushing herself to attend 5 days per week. The patient started 2nd year in Sep-2013 and attended school approximately 4 days per week because of her continued exhaustion. At that time she was pushing herself to be involved in sports but unfortunately she did not make it to the field team. The patient''s teachers informed her parents that the patient had difficulty concentrating in class and focusing at school. They felt that she was sleepy and distracted in class. She was referred to a Consultant Child Rheumatologist in Hospital in the summer of 2013 who diagnosed the patient with chronic fatigue syndrome. The consultant arranged for psychological support for the patient. The patient''s father indicated that the patient has never fully recovered. Her exhaustion continues, and she has muscle ache in her limbs. She was referred to a child Psychiatrist and has been hospitalised since 23/Feb/2015. The patient''s father indicted that the patient did not receive any further doses of HPV vaccine or any further vaccines since Sep/2012. Prior to Sep/2012 she was well and had no underlying medical conditions and received all her routine scheduled immunisations. At the time of reporting the patient had not recovered from the depression, chronic fatigue syndrome, psychological problems, and unwell. The outcome of the other events was unknown. The HPRA considered the events to be serious due to hospitalisation and medically important event.


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