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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: 574641 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2011-08-07
Onset:2012-04-01
   Days after vaccination:238
Submitted: 2015-02-05
   Days after onset:1040
Entered: 2015-02-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA138BA / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Fatigue, Headache, Loss of consciousness, Lymphadenopathy, Malaise, Mental impairment, Pain, Photophobia, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN011427

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of swollen lymph nodes in a 14-year-old female subject who received CERVARIX (batch number AHPVA138BA, expiry date unknown) and (batch number AHPVA149BA, expiry date unknown). On 7th August 2011, the subject received the 1st dose of CERVARIX (intramuscular). On an unknown date, the 2nd dose was an unknown dose. On an unknown date, the 3rd dose was an unknown dose. In April 2012, an unknown time after receiving CERVARIX, the subject experienced swollen lymph nodes (serious criteria hospitalization), headache (serious criteria hospitalization), convulsion (serious criteria hospitalization and GSK medically significant), loss of consciousness (serious criteria hospitalization and GSK medically significant, malaise (serious criteria hospitalization), intelligence decreased (serious criteria hospitalization and GSK medically significant) and generalized aching (serious criteria hospitalization). On 22nd January 2015, the outcome of the swollen lymph nodes, headaches, abdominal pain, fatigue, light sensitivity to eye, convulsion, loss of consciousness, malaise, intelligence decreased and generalized aching were not recovered/not resolved. The reporter considered the swollen lymph nodes, headache, abdominal pain, fatigue, light sensitivity to eye, convulsion, loss of consciousness, malaise, intelligence decreased and generalized aching were not recovered/not resolved. The reporter considered the swollen lymph nodes, headache, abdominal pain, fatigue, light sensitivity to eye, convulsion, loss of consciousness, malaise, intelligence decreased and generalized aching to be related to CERVARIX. From April 2012, symptoms developed in sequence.


VAERS ID: 575489 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-03-29
Onset:0000-00-00
Submitted: 2015-03-04
Entered: 2015-03-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA161BA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Amnesia, Dizziness, Dyskinesia, Mental impairment, Pain, Post vaccination syndrome, Sleep disorder
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN026855

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of post vaccination syndrome in a 16-year-old female subject who received CERVARIX (batch number AHPVA138BA, expiry date unknown), (batch number AHPVA148BA, expiry date unknown) and (batch number AHPVA161BA, expiry date unknown). On 8th August 2011, the subject received the 1st dose of CERVARIX (intramuscular). On 15th October 2011, the 2nd dose was an unknown dose. On 29th March 2012, the 3rd dose was an unknown dose. In November 2014, unknown after receiving CERVARIX, the subject experienced post vaccination syndrome (serious criteria hospitalization and clinically significant/intervention required). On an unknown date, the subject experienced intelligence decreased (serious criteria GSK medically significant), thinking reduced (serious criteria GSK medically significant), movements involuntary, dizziness, generalised aching, sleep disorder and loss of memory ability. On 25th February 2015, the outcome of the post vaccination syndrome, intelligence decreased, thinking reduced, movements involuntary, dizziness, generalised aching, sleep disorder and loss of memory ability were not recovered/not resolved. The reporter considered the post vaccination syndrome to be related to CERVARIX. It was not reported if the reporter considered the intelligence decreased, thinking reduced, movements involuntary, dizziness, generalised aching, sleep disorder and loss of memory ability to be related to CERVARIX. Involuntary movements of hands and feet appeared 2 or 3 months after vaccination. Subsequently, symptoms such as dizziness, generalized pain, and sleep disorder developed. The subject had all symptoms consistent with those of human papillomavirus vaccination associated with neuropathic syndrome (HANS) (post vaccination syndrome) such as decreased comprehension and thinking, and forgetting friends'' name and events as school. The subject was scheduled to be admitted to epilepsy center. The subject had typical symptoms associated with HANS.


VAERS ID: 576284 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-03-11
Entered: 2015-03-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Hallucination, Loss of personal independence in daily activities, Mental disorder
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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: Contraceptive pill (trade name unknown)
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LU2015GSK028619

Write-up: This case was reported by a physician via other manufacturer and described the occurrence of hallucination in a 17-year-old female patient who received CERVARIX. Concomitant products included hormonal contraceptives for systemic use (trade name unknown). On an unknown date, the patient received CERVARIX (unknown) .5 ml. In 2014, an unknown time after receiving CERVARIX, the patient experienced hallucination (serious criteria other: medically significant) and psychiatric disorder nos. On an unknown date, the outcome of the hallucination and psychiatric disorder nos were unknown. It was unknown if the reporter considered the hallucination and psychiatric disorder nos to be related to CERVARIX. Additional details were provided as follows: This case was received from other manufacturing company (Pfizer). The patient''s medical history was not reported. Initially, 3 suspect vaccines were mentioned as PREVENAR 13, diphtheria toxoid poliomyelitis vaccine inactivated and hepatitis B vaccine, but later it was confirmed that the patient received CERVARIX only. In 2014, an unknown time after vaccination with CERVARIX, the patient experienced hallucination and psychiatric disorder. The patient needed to interrupt school for 2 to 3 months.


VAERS ID: 575837 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-03-05
Onset:2013-05-01
   Days after vaccination:57
Submitted: 2015-03-12
   Days after onset:680
Entered: 2015-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Brain scan abnormal, Cerebral hypoperfusion, Educational problem, Mental disability, Palpitations, Single photon emission computerised tomogram abnormal
SMQs:, Arrhythmia related investigations, signs and symptoms (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), Embolic and thrombotic events, arterial (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Cardiomyopathy (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (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? 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: JP2015JPN031236

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of palpitations in a 15-year-old female subject who received CERVARIX. On 26th August 2012, the subject received the 1st dose of CERVARIX (intramuscular). On 3rd October 2012, the 2nd dose was an unknown dose. On 5th March 2013, the 3rd dose was an unknown dose. In May 2013, unknown after receiving CERVARIX, the subject experienced palpitations (serious criteria hospitlalization) and cerebral hypoperfusion (serious criteria hospitalization and GSK medically significant). On an unknown date, the subject experienced mental disequilibrium. On 21st November 2014, the outcome of the palpitations, cerebral hypoperfusion and mental disequilibrium were recovered/resolved. The reporter considered the palpitations and cerebral hypoperfusion to be related to CERVARIX. It was not reported if the reporter considered the mental dyseuilibrium to be related to CERVARIX. May 2013: Palpitations appeared. June 2013: The symptom of palpitations was aggravated. December 2013: The subject visited the reporter''s department for the first time. Cerebral blood flow single photon emission computerized tomography (SPECT) showed decreased blood flow in the cerebral cortex (cerebral hypoperfusion). The symptom temporarily improved with high-dose steroid therapy. June 2014: The symptom of cerebral hypoperfusion was aggravated. The subject was admitted to the reporter''s department and underwent blood purification therapy 19 times in total. Since the subject''s mental condition became unstable during the procedure, the subject was transferred to the department of psychiatry. The symptom improved with oral steroid and blood purification therapy. November 2014: the subject was discharged from the hospital to home. It took approximately one year from the start of the treatment to the improvement of the symptoms. The subject inevitably repeated the same grade in the university.


VAERS ID: 576086 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-11-13
Onset:2014-02-15
   Days after vaccination:94
Submitted: 2015-03-18
   Days after onset:395
Entered: 2015-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Autonomic nervous system imbalance, Cognitive disorder, Dizziness, Exercise tolerance decreased, Headache, Hypersomnia, Hypotension, Labile blood pressure, Meningitis, Mental impairment, Psychomotor hyperactivity, Pyrexia, Tilt table test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Akathisia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Hostility/aggression (broad), Hypertension (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (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: Dizziness; Immunisation
Preexisting Conditions: Meningitis, The patient''s medical history was relevant for an about 10-year-old severe meningitis sequelae in form of attacks approximately once a month with transient dizziness; 06/24/2013, GARDASIL; Drug indication: Immunisation; 04/25/2013, GARDASIL; Drug indication: immunization, previous doses of GARDASIL were given on 25-Apr-2013 (D1) and 24-Jun-2013 (D2). Toleration was not reported.
Allergies:
Diagnostic Lab Data: Tilt table test, very labile, low blood pressure, but no POTS not provided
CDC Split Type: WAES1503DNK007325

Write-up: Information has been received from Sanofi Pasteur MSD [DK-1577272925-E2015-02545] on 13-MAR-2015. Case received from health professional via the Health Authorities on 11-Mar-2015 under the reference number DK-DKMA-ADR 22900714 and DK-DKMA-EFO11346. Case was medically confirmed. Primary source was a physician. A 15-year-old female patient (weight 55 kg, height 156 cm) had received the third injection of GARDASIL (batch number not reported, dose 0.5 ml) intramuscularly into not reported site of administration on 13-Nov-2013. The patient''s medical history was relevant for an about 10-year-old severe meningitis sequelae in form of attacks approximately once a month with transient dizziness. Previous doses of GARDASIL were given on 25-Apr-2013 (D1) and 24-Jun-2013 (D2). Toleration was not reported. Approximately 3 months after the third vaccination, on 15-Feb-2024, the dizziness suddenly was constant (dizziness aggravated) and the patient developed also developed autonomic dysfunction, muscular hyperactivity (tremor/twitch), severe cognitive dysfunction, sleep excessive (increased need for sleep), feeling feverish, and very pronounced intolerance to both physical and mental activity. On 05-Apr-2014, the patient also experienced chronic headaches. The patient was hospitalized on an unspecified date. It was unknown whether examinations were performed or lab samples were taken. A tilt table showed very labile and low blood pressure, but not really orthostatic hypertension and did not meet the criteria for POTS. It was unknown whether other vaccines or medications were administered. Both the patient''s family and the reported had doubts about what was due to meningitis sequelae and what was suspected to be a reaction to the GARDASIL vaccine. The patient''s condition as slowly improving. She had been home from school for months but was now slowly coming back again. At the time of reporting, the patient was recovering from the event of chronic headaches. The outcome of the events feeling feverish and exercise intolerance was unknown. The patient had not recovered from all other events.


VAERS ID: 576303 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-05-09
Onset:2015-01-08
   Days after vaccination:244
Submitted: 2015-03-23
   Days after onset:73
Entered: 2015-03-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Chest X-ray, Chest pain, Cyanosis, Dyspnoea, Echocardiogram, Electrocardiogram, Exercise tolerance decreased, Gait disturbance, Hypoaesthesia, Mental impairment, Mobility decreased, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Oxygen saturation decreased, Syncope, Vitamin D decreased, Vitamin D deficiency, Wheelchair user
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), 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 (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Infective pneumonia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood test, vitamin D deficiency; Chest X-ray, Not provided; Echocardiogram, Not provided; Electrocardiogram, Not provided; Nuclear magnetic resonance imaging, Head and spine; Oxygen saturation, Significantly low
CDC Split Type: WAES1503GBR009990

Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number GB-1577272925-E2015-02692) on 19-MAR-2015. Initial case received on 16-Mar-2015 from the health authority GB-MHRA ADR 228896372. This case is not medically confirmed. A 14 year old female patient (weight 76 kg), with no medical history reported, received an injection of GARDASIL, (batch number not reported) on 09-Oct-2013 and an injection of GARDASIL (batch number not reported) on 09-May-2014, doses in series, routes and sites of administration not reported. On 08-Jan-2015, when the patient was talking with friends, she suddenly could not breathe and collapsed. On the same date, she could not walk down the stairs and took the lift, she collapsed again and then she experienced chest pain. The patient''s mother was called and school reported that the patient presented with blueness round her mouth and her lips were fully blue. The patient''s mother advised accident and emergency and shortness of breath continued until accident and emergency. Oxygen saturation levels in accident and emergency were significantly low and the patient was admitted to ward immediately. Chest pain was treated with pain killer paracetamol, ibuprofen and codeine. On 08-JAN-2015, the patient noticed that she could not feel her feet and hands and this increased to numbness of whole legs to hip and arms to shoulder. Physiotherapy treatment was introduced. Then, the patient could not move arms and legs but was able to stand on her legs and walk. On an unreported date after the vaccine, the patient had difficulty exerting either mentally of physically for long periods of time. On an unreported date, blood test, chest X-ray, electrocardiogram, echocardiogram and MRI of head and spine were performed and it was only suggested vitamin D deficiency. The patient was in ward hospital for a month. She saw a paediatric psychologist for support with mobility change. The patient was in wheelchair bound and downstairs living. The patient''s symptoms have not worsened but stayed the same since admittance, except for breathing issues which worsen when chest pain increased. On an unreported date, the patient had recovered from syncope. At the time of reporting, the outcome for cyanosis and vitamin D deficiency was unknown and the patient had not yet recovered from the other adverse events. The case was considered as serious due to the patient''s hospitalization and disability.


VAERS ID: 576884 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2013-04-20
Onset:2013-04-27
   Days after vaccination:7
Submitted: 2015-04-09
   Days after onset:712
Entered: 2015-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA162CA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Headache, Mental impairment, Pain, Visual acuity reduced
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN045249

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of cerebration impaired in a 12-year-old female subject who received CERVARIX (batch number AHPVA162CA, expiry date unknown). Concomitant products included Japanese Encephalitis vaccine. On 20th April 2013, the subject received CERVARIX. On 27th April 2013, unknown after receiving CERVARIX, the subject experienced arthralgia. On 11th January 2015, the subject experienced headache. In February 2015, the subject experienced pain and visual acuity reduced. On an unknown date, the subject experienced cerebration impaired (serious criteria GSK medically significant and clinically significant/intervention required). On an unknown date, the outcome of the cerebration impaired, arthralgia, headache, pain and visual acuity reduced were not recovered/not resolved. The reporter considered the cerebration impaired, arthralgia, headache, pain and visual acuity reduced to be related to CERVARIX. Family history: Behcet''s disease. On 11 May 2013, the subject received the third dose of Japanese encephalitis vaccine. Arthralgia persisted.


VAERS ID: 577420 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-04-21
Entered: 2015-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Asthenia, Blood test, Borderline personality disorder, Cold sweat, Depression, Dyspnoea, Emotional disorder, Fatigue, Feeling cold, Headache, Hyperhidrosis, Mental impairment, Muscle twitching, Palpitations, Paraesthesia, Post-traumatic stress disorder, Restlessness, Syncope, Tremor, Urinary hesitation, Urine output decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Acute renal failure (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1504DNK018171

Write-up: Information has been received from Sanofi Pasteur MSD (Manufacturer control number: E2015-03632) on 17-APR-2015, as a part of business agreement. Case received from a consumer or other non health care professional via the Health Authorities on 14-Apr-2015 under the reference number DK-DKMA-ADR 22944286 and DK-DKMA-EFO11625. Case is not medically confirmed. Primary source was a consumer. A 15-year-old female patient (weight 50 kg, height 170 cm) with no medical history reported had received three injections of GARDASIL, batch numbers not reported via intramuscular route into not reported site of administration on unspecified dates in 2007. On unspecified dates in 2007, the patient developed fainting, constant severe tremors of the hands/tingling and twitching in the fingers, tremors/restless feeling inside the body especially in the chest and stomach (e.g. anxiety, stress, fear exacerbates it), depression/cannot control feelings/not capable to make a decision or consider several things at the same time/emotionally out of balance, palpitations (also, other places than chest), frequent headache, constantly exhausted and low energy, difficulty breathing, freezing and sweating at the same time/extreme cold sweat on feet, anxiety, problems urinating (small amount of urine), stress, post traumatic stress syndrome (PTSD), and borderline personality disorder. The patient had not been hospitalized due to the adverse reaction. According to the patient, she had had the above mentioned adverse reactions throughout many years, and had visited several doctors due to the adverse reactions and had taken several blood tests. She stated the following "Unfortunately, I have a very disconnected doctor and a doctor that does not engage fully in his patients and does not go "deeper" than what is apparent. "It is only a virus", "It will certainly pass", "come back in 14 days if it is not better". (but I cannot just keep on coming back and back). Have been to neurologist due to the tremors of the hands as they are a big problem, but he had no explanation. I have learnt to live with the "adverse reactions", for example when I am close to fainting and I known that I should sit down and have some water and keep calm for 10-20 min have gradually learned that, but it happens constantly that I do not manage it. My mother saw the TV broadcast about the HPV vaccines and called me immediately, as it all made sense to her all of a sudden. When I went to my doctor for referral; he asked me, in all seriousness, to leave. I can understand, in hindsight, that he is tired of me and all of my problems and about that we/he does not know what is wrong with me. But he should just know, how I have it. Still do not think that he has realized that. My mother has gotten him to refer me to the Syncope center, and now I have reported the adverse reactions/problems I am struggling with." The patient is a patient in DBT-treatment at a psychiatric center. Concomitant medication was not reported. At the time of reporting, the patient had not recovered.


VAERS ID: 577410 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2012-04-01
Submitted: 2015-04-21
   Days after onset:1115
Entered: 2015-04-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Alopecia, Blood test normal, Cerebrovascular accident, Computerised tomogram normal, Diplopia, Disturbance in attention, Eye pain, Eye patch application, Fall, Head injury, Headache, Hypermetropia, Hypersomnia, Influenza like illness, Lumbar puncture abnormal, Magnetic resonance cholangiopancreatography, Mental disorder, Neurological examination normal, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Thrombosis, VIth nerve paralysis, Visual impairment, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Ocular motility disorders (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: CILEST
Current Illness: Contraception; Migraine with aura; Immunisation
Preexisting Conditions: 2011, Fall; 2011, Haemorrhage
Allergies:
Diagnostic Lab Data: On 17-APR-2012, blood test: normal, infection counts were normal; On 20-APR-2012, CT scan showed normal conditions; On 23-APR-2012, Neurological examinations showed normal conditions; On 04-MAY-2012, CT scan: normal; 04/20/2012, Lumbar puncture, confirmed stroke; 07/12/2012, Magnetic resonance cholangiopancreatography, showed changes on both right and left side; 05/04/2012, Neurological examination, N/A; 04/20/2012, Nuclear magnetic resonance imaging, confirmed stroke; 05/04/2012, Nuclear magnetic resonance imaging, showed signs of inadequate flow; 04/30/2012, Physical examination, condition not worsened
CDC Split Type: WAES1504DNK018857

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (DK-1577272925-E2015-03689) on 20-APR-2015. Case received from health care professional via the Health Authorities on 15-Apr-2015 under the reference number DK-DKMA-ADR 2264573 and DK-JNJFOC-20130914343. Case is medically confirmed. Primary source was a physician. A 17-year-old female patient (weight, height not reported) received a complete vaccination series with three doses of GARDASIL, (batch numbers not reported) intramuscularly into not reported site of administration on 20-Oct-2008 (D1), on 09-Dec-2008 (D2) and on 16-Apr-2009 (D3). The patient also received orally CILEST, (MFR other, 250+25 microgram, batch number not reported) for contraception from 08-Feb-2012 to Apr-2012. CILEST was also considered suspect drug. The patient''s medical history included migraine with aura. Because of several falls from a horse a magnetic resonance imaging (MRI) scan was performed in Dec-2011. This scan showed haemorrhages. Concomitant medications were not reported. There was no inherited predisposition to thrombosis and the blood pressure was normal. There were no contraindications despite of known migraines. The patient visited the doctor on 13-Apr-2012. The patient experienced influenza like symptoms for a couple of days and had headache over the forehead. The pain was mainly centered to the left side, and she had a proper sensation in the ear. No visual disturbances or nausea was noted. It was decided to wait and see. On examination at the family doctor on 17-APR-2012, the patient was generally affected and she could barely stay awake for meals. The rest of the day she was sleeping. Blood tests were taken to check for a suspicion glandular fever. The blood test results were available on 19-APR-2012 and were normal as well as infection counts. On 20-Apr-2012, a new examination was performed. The patient had headache behind the eyes. The patient had been vomiting for 6 days and had beginning of visual disturbances. It was informed that the patient had fallen during winter holiday and hit the back of her head. Because of the risk of a haematoma she was hospitalised on the same day. Acute CT scan was done and it showed normal condition. A lumbar puncture and MRI scan were performed due to suspected stroke. MRI scan confirmed stroke. Anticoagulant treatment with FRAGMIN and MAREVAN was initiated. It was believed that the stroke was triggered by a combination of birth control pills, influenza, possible light dehydration, and possible faults in coagulation cascade. A neurological investigation was performed on 23-Apr-2012. This showed normal conditions. The patient was discharged on 28-Apr-2012. On 30-Apr-2012 the patient was again examined as her conditions had slightly worsened. The patient was examined but was believed that the condition was not worsened. It was agreed that the patient should consult her family doctor after 2-3 days to follow-up the treatment with blood thinners. On 04-May-2012, the patient was hospitalised again due to difficulties in concentrations and double visions when looking in all directions. Neurological examination and a CTC scan were performed. Both results were normal. Even a new MRI scan was performed. This showed signs of inadequate flow. A surgery removal of the clot was considered (thromboectomia) but it was decided to wait and see. The dose of MAREVAN was increased. On 10-May-2012, the patient informed that she was feeling better. However, she was disturbed by double vision. The patient was using eye patch to reduce the symptoms. The patient was remitted to squint clinic. The patient was discharged 15-May-2012, sixth-nerve palsy was still occurring (paralysis of the muscle moving the eye). The patient had decreased headache on 13-Jun-2012. There was only marginally double vision in certain situation. On 05-Jul-2012, the patient started treatment on vision. On 12-Jul-2012, a magnetic resonance cholangiopancreatography (MRC) scan was performed. It showed changes on both left and right side. The patient had resumed her daily activities with some problems with MAREVAN treatment. The patient was suggested to have new MRC scan after 3 months. It appeared from the medical records from 01-Oct-2012 that the patient wanted to stop the MAREVAN treatment as she experienced the adverse reaction alopecia. It was considered that there was a continuing need for MAREVAN treatment. It was recommended to continue the treatment. On 06-Nov-2012, MAREVAN treatment was recommended for further 12 months as there were still some complications following the stroke. There was still alopecia tendency. The patient discontinued the MAREVAN treatment on 26-Jan-2013. Treatment with CILEST was withdrawn. The patient was recovering from stroke and had not recovered from sixth palsy at the time of the report. The outcome for influenza like symptoms was not reported. On 18-Sep-2013 Agency had received this case also from the Patient Insurance Company. PIC decided that the patient''s injury in the form of stroke and the consequences are covered by the law and that the patient is preliminarily entitled to compensation for pain and suffering. PIC had assessed that the patient''s stroke was due to the treatment with CILEST during the period from 08-Feb-2012 to Apr-2012. PIC had when making their decision considered that it is a known but rare adverse reaction to get a stroke after treatment with CILEST. PIC had also considered that the injury in the form of extended sick course and a possible permanent injury is serious in relation to that the treatment with CILEST was not due to a disease or similar, but was only to prevent pregnancy. The patient was therefore entitled to compensation for the consequences of treatment with CILEST. Agency received decision from PIC on 31-Jan-2014. Regarding health related expenses PIC was aware that the patient had been exposed to a unpleasant course of events due to her stroke, and that she for that reason temporarily had a need for psychologist help. PIC had considered that the patient''s temporary expense to psychologist was a result of the injury and that she therefore was entitled to compensation. Although, the patient has no permanent injury an evaluation from eye doctor was retrieved. It appeared of this, that the patient sees 1.0 (normal) on both eyes with a slight farsightedness correction at +1.0, sphere. It is not amblyopia, double vision or strabismus. With this as background, PIC assessed that the patient does not have permanent physical problems after the drug injury. The reporter had informed that the patient had received lasting psychic disturbance as a result of the injury. PIC was aware of that the patient had been through an unpleasant passage of events that most likely had affected her psychological state in shorter problems. However, PIC did not consider that the injury or resulting course of events had been of such character that was suitable to cause lasting psychological problems corresponding to 5% or more, which is a condition to be considered a permanent injury. Thus, the patient was not entitled to compensation for permanent injury. Regarding loss of income: reporter had in a letter from 13-Oct-2013 informed that the patient was forced to give up her dream of becoming a fighter pilot due to the injury. PIC had assessed that the patient had not been caused permanent harm by the drug injury. For that reason, PIC believed that the injury was not why she had given up her dream of becoming a fighter pilot. It shall be noted that loose dreams of becoming a pilot fighter in the future is not enough documentation that it had actually happened. Non-concrete plans and wishes of making a career within a certain field is thus insufficient documentation to substantiate a future permanent revenue loss that entitles to compensation for income loss. Agency received additional information from a physician on 01-Jul-2014. The patient was treated with KODIPAR, EMPERAL, MAREVAN and TRADOLANL. The reporters assessed that the need for the medication was a result of treatment injury. Agency received information from the patient''s general practitioner (GP) on 08-Apr-2015. The GP informed that the patient and her parents mean that occurrences related to this case are caused by GARDASIL. The physician believed that the probability for this is very small but that it can not be ruled out that GARDASIL may have had a role. Agency added therefore GARDASIL to this case as suspect drug. This case is part of two cases and is linked to case E2015-03679 (DK-DKMA-ADR 22944437) in regard to GARDASIL/CERAZETTE and the reactions of lung embolism, arthralgia, lupus erythematosus cells and APS in 2015.


VAERS ID: 577559 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-04-23
Entered: 2015-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Back pain, Chest pain, Cold sweat, Confusional state, Disturbance in attention, Fatigue, Hot flush, Impaired work ability, Insomnia, Loss of personal independence in daily activities, Memory impairment, Menstrual disorder, Mental status changes, Mood swings, Muscular weakness, Neck pain, Paraesthesia, Tonsillar hypertrophy, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Arthritis (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: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1504DNK018616

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # E2015-03710) on 20-APR-2015. Case received from non-health professional via the Health Authorities on 16-Apr-2015 under the reference number DK-DKMA-ADR 22945706 and DK-DKMA-EFO11640. Primary reporter was consumer. A previously healthy 13 year-old female patient (weight 54kg and height 167cm), had received two dose of GARDASIL (batch number not reported) intramuscularly into unspecified site of administration on unspecified dates in 2010 and 2011. On an unspecified date in 2012, the patient developed mental changes, tingling skin, tiredness, swollen tonsils, weakness, sleeplessness, muscle weakness, concentration difficultly, cannot focus mentally, tremor in hands and arms, problems with short-term memory, besides herself, cold sweat, hot flushes, significant menstruation problems, stomach pain, periodic chest pain, neck pain, confused, mood swings, joint pain and pain in back. The patient has absence from school and has ceased work. The patient has received the following treatment for the adverse reaction: stomach pain treated with omeprazole (other MFR). The patient is referred to a HPV center for diagnosis of adverse reactions. The patient has not been hospitalized because of the adverse reactions. At the time of reporting, the patient was not recovered. Upon medical review the company judged relevant to consider the case as serious due to absence of school and terminated job.


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