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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: 588576 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-07-28
Entered: 2015-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NH31140 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Asthenia, Blood test abnormal, Cognitive disorder, Constipation, Dyspnoea, Fatigue, Gait disturbance, Headache, Menstruation irregular, Mental disorder, Nausea, Ovulation pain, Photosensitivity reaction, Syncope, Wound
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (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), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (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: 2007, GARDASIL
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1507DNK012326

Write-up: Information has been received from Sanofi Pasteur (manufacturer control # E2015-08536) on 27-JUL-2015. Case received from consumer via Health Authorities on 23-Jul-2015 under the reference numbers DK-DKMA-ADR23071943 and DK-DKMA-WBS-0000444. The primary reporter was a consumer. A 20 year-old female patient (weight: 95 kg; height: 183 cm) with no information on medical history reported, had received dose 3 of GARDASIL, (batch number not reported) via i.m route of administration in unspecified site of administration on an unspecified date in 2007 and later on an unspecified date in 2012 she developed chronic tiredness, constipation, irregular menstruation, ovulation pain, in 2013 pain in joint, cognitive impairment, headache, shortness of breath, chronic nausea, declined strength (general weakness), mental instability, spontaneous wounds on hands, scalp, nose and mouth, in 2014 dizziness, sensitive to sun light, prone to fainting, unspecified date cannot walk particularly well and pain. The patient has previously received dose 1 and 2 of GARDASIL (batch number not reported) on unspecified dates in 2007 via i.m route and unspecified site of administration. The patient has been treated with the following for the adverse event: PLAQUENIL, mfr other), acupuncture, healing, provocation test, therapy group. The patient has not been hospitalized due to adverse events. The patient was vaccinated with GARDASIL in 2007 and received all three vaccinations. The patient experienced proneness to fainting a few times a week. She has fainted at least three times since Christmas 2014. No other medicines. The HA has asked the Hospital for medical confirmation. Examinations and laboratory tests: the patient has been suspected of lupus in two years despite missing several "positive" blood tests (the patient''s own physician does not believe that this is due to GARDASIL vaccine). At the time of reporting, the patient had not yet recovered.


VAERS ID: 588985 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-07-31
Entered: 2015-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Acne, Alopecia, Altered state of consciousness, Androgens increased, Balance disorder, Blood oestrogen increased, Cognitive disorder, Diplopia, Disturbance in attention, Dizziness, Dry eye, Dry mouth, Dry skin, Dyspnoea, Excessive cerumen production, Fatigue, Feeling hot, Food allergy, Hair disorder, Headache, Hormone level abnormal, Hypersomnia, Hypoaesthesia, Liver disorder, Liver function test abnormal, Loss of personal independence in daily activities, Malaise, Mental disorder, Milk allergy, Pain, Paraesthesia, Progesterone decreased, Pyrexia, Sensory loss, Temperature regulation disorder, Thyroid disorder, Vision blurred
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Ocular motility disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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? 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: DK2015108528

Write-up: This case was reported by a consumer via regulatory authority and described the occurrence of malaise in a female patient who received Human papilloma type 16 + 18 vaccine. On an unknown date, the patient received Human papilloma type 16 + 18 vaccine (intramuscular) 1 dose form(s). On an unknown date, unknown after receiving Human papilloma type 16 + 18 vaccine, the patient experienced malaise (serious criteria disability), fatigue (serious criteria disability), fever (serious criteria disability), sleep excessive (serious criteria disability), consciousness disturbed (serious criteria disability and GSK medically significant), headache (serious criteria disability), pain (serious criteria disability), numbness localized (serious criteria disability), thyroid disorder (serious criteria disability), difficulty breathing (serious criteria disability), hormonal imbalance (serious criteria disability), androgens high (serious criteria disability), estrogen increased (serious criteria disability), progesterone decreased (serious criteria disability), acne aggravated (serious criteria disability), blurred vision (serious criteria disability), double vision (serious criteria disability), pins and needles (serious criteria disability), temperature regulation disorder (serious criteria disability), feeling hot (serious criteria disability), dry eyes (serious criteria disability), dry mouth (serious criteria disability), dry skin (serious criteria disability), ear wax (serious criteria disability), cognitive impairment (serious criteria disability), dizzy (serious criteria disability), balance difficulty (serious criteria disability), concentration impaired (serious criteria disability), hair loss (serious criteria disability), protein allergy (serious criteria disability), milk protein allergy (serious criteria disability), impaired liver functions (serious criteria disability) and activities of daily living impaired (serious criteria disability). Human papilloma type 16 + 18 vaccine was discontinued (Dechallenge was unknown). Rechallenge with Human papilloma type 16 + 18 vaccine was unknown. On an unknown date, the outcome of the malaise and difficulty breathing were not recovered/not resolved and the outcome of the fatigue was recovered/resolved and the outcome of the fever, sleep excessive, consciousness disturbed, pain, numbness localized, thyroid disorder, hormonal imbalance, androgens high, estrogen increased, progesterone decreased, acne aggravated, blurred vision, double vision, pins and needles, temperature regulation disorder, feeling hot, dry eyes, dry mouth, dry skin, ear wax, cognitive impairment, dizzy, balance difficulty, concentration impaired, hair loss, protein allergy, milk protein allergy, impaired liver function and activities of daily living impaired were unknown and the outcome of the headache was recovering/resolving. It was unknown if the reporter considered the malaise, fatigue, fever, sleep excessive, consciousness disturbed, headache, pain, numbness localized, thyroid disorder, difficulty breathing, hormonal imbalance, androgens high, estrogen increased, progesterone decreased, acne aggravated, blurred vision, double vision, pins and needles, temperature regulation disorder, feeling hot, dry eyes, dry mouth, dry skin, ear wax, cognitive impairment, dizzy, balance difficulty, concentration impaired, hair loss, protein allergy, milk protein allergy, impaired liver function and activities of daily living impaired to be related to Human papilloma type 16 + 18 vaccine. RA verbatim text: She only had two vaccines, because she felt so unwell. Extreme tiredness, slept constantly more than 18 hours in a 24 hour period for approximately 8 months. Fever that made her sleep loads and was waving in and out of consciousness. Extreme headaches that over 8 months turned into strong pressure headaches. She only have mild headaches now, but she hardly ever had headaches before. Pain and aches. Feeling like she couldn''t feel her little toe and two fingers. Thyroid problems, took thyroxine for a while. Breathing problems - she was asked to use an inhaler, which she still does. Hormone imbalances, - high levels of androgens and oestrogen and low levels of progesterone. She was asked to take the pill as she had a coil. Extreme acne. She has always had acne, but never this bad. Vision problems: blurred vision, but main problem was double vision that occurred especially when tired, so constantly. Pins and needles in hands and feet. Completely unable to regulate body temperature, sometimes felt like lying in the snow to cool down, but felt it would be socially strange. Dry eyes, mouth, and skin in addition to loads of ear wax. Cognitively disorientated. Dizzy and difficulties balancing. Unable to concentrate. Unable to focus. Unable to process information. Hair loss, she has very thick hair and it is only looking back that she can see that she was losing. She was diagnosed with thyroid problems, hormone imbalances, protein allergy and it was suspected that a tick could have bitten her due to her nerve problems. She was told that her liver values looked like those of strong alcoholics - this was attributed to milk protein allergy. Felt a little better after stopping all intake of milk products, but not much and the result was not constant. Most doctors seems to think that she had mental problems.


VAERS ID: 607306 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-09-12
Onset:0000-00-00
Submitted: 2015-08-12
Entered: 2015-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Asthenia, Asthenopia, Chest pain, Condition aggravated, Confusional state, Constipation, Crying, Decreased appetite, Depression, Diarrhoea, Disturbance in attention, Dizziness, Dyspepsia, Dysphagia, Dysphonia, Dyspnoea, Ear discomfort, Eye pain, Eyelid oedema, Fatigue, Feeling drunk, Gait disturbance, Genital pain, Headache, Hot flush, Hypersensitivity, Injection site pain, Insomnia, Learning disability, Malaise, Memory impairment, Mental disorder, Mood swings, Nausea, Oesophageal pain, Oropharyngeal pain, Pain, Paraesthesia, Skin disorder, Sleep disorder, Stress, Tinnitus, Tremor, Vision blurred
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Immunisation; 2006, Migraine; 2006, Headache
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1508DNK004426

Write-up: Information has been received from Sanofi Pasteur MSD (reference No. DK-1577272925-E2015-09105) as a part of a business agreement on 11-AUG-2015. Case received from health professional via Health Authorities on 06-Aug-2015 under the reference number DK-DKMA-ADR 23093310 and DK-DKMA-WBS-0000581. The primary reporter was physician. A 14-years-old female patient (weight: 73kg; height: 168cm) with a medical history of headache and migraine, had received three doses of GARDASIL, batch/lot number not reported for dose 1 and 3 and NG43420 for dose 2 via im. route of administration in not reported site of administration on 14-Mar-2008, 09-May-2008 and 12-Sep-2008 and later on 30-Nov-2008 she developed abdominal pain (abdominal cramp tender in abdominal pain in abdomen), headache (pain in head pain cranial pain) (aggravated) and stress (easy stressed) and on unspecified date concentration problems, learning difficulties, very bad memory cannot remember much, cannot cope handle several things at the same time cannot cope manage much, pain in eyes, heavy eyelid, swollen eyelid, blurred vision, difficult focusing, pressures in ear, diarrhoea, constipation, difficult swallowing, pain in esophagus, pain in throat, genital pain, chest pain, unsteady walking, sleeplessness, sleep problems, easy to cry, mental unstable, mood swings, periodic tinnitus, heartburn, hoarseness, pain when looking up to the side, turn the head, shock throughout the body and head every time in whole body, tenderness at the injection site, very unclean skin and ugly skin, severe red stribes, patches and marks, migraine aggravation, raising on skin, malaise, feeling ill, feeling that she has been very hard affected by the disease, dizziness, almost constant feeling of sensitivity, shoulder pain, pain in neck, pain in back, unnormal tiredness lack of energy and tired, weakness in hands, fingers, and arms, shaking hands and arms, tingling pricken sensation in body, muscle pain, joint pain, pain in knee, nausea, strong menstrual pain, reduces appetite, easy confused, restless in body, restlessness, can never relax properly, restlessness in whole body, feel fast the she get suffocated of warm and bad air constant need of air, feeling drunk, not normal weakness, lack of energy no strengths, depression, pain in legs feet, easy pain in tailor bone and collarbone, have it really bad constantly. The physician reports that some of the symptoms were present before vaccination but got worse. The physician had reported the following reactions: headache, abdominal pain, and stress. In addition the physician informs that the patient says that she has experienced the reported reactions. The dates and symptoms are fictive, as the symptoms have come continuously during the years after vaccination. The patient describes that a typical day proceeds with abdominal pain, headache, feeling ill, dizziness, feeling of being hard affected of the disease, lack of energy and tired, hot flushes, too hot all the time, constant need of air, feel fast the she get suffocated of warm and bad air, almost constant feeling of fainting, feeling drunk, tingling and restlessness in body, restless, cannot figure out how to relax, cannot handle, manage, remember very much. Need to fight every day to be able to keep something out. Have constantly and continuously it very bad. Has very hard to attend school and work. Have many sick days. Has very hard to concentrate and to learning. Never experiences a normal day with normal health. The patient has been thoroughly examined for abdominal pain with blood test and hospital evaluation. The patient has a medical history of headache and migraine since 2006. At the time of reporting, the patient had recovered from depression not recovered for headache abdominal pain and stress and unknown for all others. The case has been considered as serious according to the disability criteria.


VAERS ID: 608013 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-03-24
Onset:2012-04-01
   Days after vaccination:8
Submitted: 2015-08-25
   Days after onset:1241
Entered: 2015-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA161BA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthritis, Autonomic nervous system imbalance, Cranial nerve disorder, Headache, Mental impairment, Neurological symptom, Pain, Post vaccination syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN118661

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of post vaccination syndrome in a female subject who received CERVARIX (batch number AHPVA146AA, expiry date unknown), (batch number AHPVA148BA, expiry date unknown) and (batch number AHPVA161BA, expiry date unknown). On 13th September 2011, the subject received the 1st dose of CERVARIX (intramuscular). On 23rd October 2011, the 2nd dose was an unknown dose. On 24th March 2012, the 3rd dose was an unknown dose. In April 2012, unknown after receiving CERVARIX, the subject experienced post vaccination syndrome (serious criteria clinically significant/intervention required), pain (serious criteria clinically significant/intervention required), arthritis (serious criteria clinically significant/intervention required), headache (serious criteria clinically significant/intervention required), Dysautonomia (serious criteria clinically significant/intervention required), cranial nerve disorder (serious criteria clinically significant/intervention required) and cerebration impaired (serious criteria GSK medically significant and clinically significant/intervention required). On an unknown date, the outcome of the post vaccination syndrome, pain, arthritis, headache, Dysautonomia, cranial nerve disorder and cerebration impaired were not recovered/not resolved. It was not reported if the reporter considered the post vaccination syndrome, pain, arthritis, headache, Dysautonomia, cranial nerve disorder and cerebration impaired to be related to CERVARIX. The subject developed intense headache after the third vaccination, and the pain spread to the whole body. In addition to this, higher brain dysfunction developed and persisted to present, along with the various symptoms involving autonomic and cranial nerves. As of 17 August 2015, the outcome was unresolved. A typical Human papillomavirus vaccination associated with neuropathic syndrome (HANS) was suspected.


VAERS ID: 608108 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-12-07
Onset:2012-07-01
   Days after vaccination:207
Submitted: 2015-08-27
   Days after onset:1152
Entered: 2015-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA148BA / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Autonomic nervous system imbalance, Endocrine disorder, Memory impairment, Menstruation irregular, Mental impairment, Temperature regulation disorder
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Fertility disorders (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:
CDC Split Type: JP2015JPN120762

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of cerebration impaired in a female subject who received CERVARIX (batch number AHPVA148BA, expiry date unknown). On 2nd November 2011, the subject received the 1st dose of CERVARIX (intramuscular). On 7th December 2011, the 2nd dose was an unknown dose. In July 2012, an unknown time after receiving CERVARIX, the subject experienced cerebration impaired (serious criteria disability and GSK medically significant). On an unknown date, the subject experienced dysautonomia, temperature regulation disorder, memory impairment, endocrine disorder and irregular menstrual cycle. On an unknown date, the outcome of the cerebration impaired was not recovered/not resolved and the outcome of the dysautonomia, temperature regulation disorder, memory impairment, endocrine disorder and irregular menstrual cycle were unknown. The reporter considered the cerebration impaired to be related to CERVARIX. It was not reported if the reporter considered the dysautonomia, temperature regulation disorder, memory impairment, endocrine disorder and irregular menstrual cycle to be related to CERVARIX. Family history: Asthma. As of August 19, 2015, the outcome of the cerebration impaired was not recovered/not resolved and the outcome of the dysautonomia, temperature regulation disorder, memory impairment, endocrine disorder and irregular menstrual cycle were unknown. Other possible etiological factor: None.


VAERS ID: 608987 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-09-20
Onset:0000-00-00
Submitted: 2015-09-07
Entered: 2015-09-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA148AA / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Cognitive disorder, Diplegia, Mental impairment, Pain, Plasmapheresis, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), 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), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 55 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN124266

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of spastic diplegia in a 15-year-old female subject who received CERVARIX (batch number AHPVA148AA, expiry date unknown), (batch number AHPVA148CB, expiry date unknown) and (batch number AHPVA161BA, expiry date unknown). On 20th September 2011, the subject received the 1st dose of CERVARIX (oral). On 24th October 2011, the 2nd dose was an unknown dose. On 26th March 2012, the 3rd dose was an unknown dose. In October 2011, 30 days after receiving CERVARIX, the subject experienced tachycardia (serious criteria hospitalization). In February 2013, the subject experienced spastic diplegia (serious criteria hospitalization and GSK medically significant). In 2013, the subject experienced cognitive disorder. On an unknown date, the subject experienced cerebration impaired (serious criteria GSK medically significant) and pain. On an unknown date, the outcome of the spastic diplegia and tachycardia were recovering/resolving and the outcome of the cerebration impaired, cognitive disorder and pain were unknown. The reporter considered the spastic diplegia and tachycardia to be related to CERVARIX. It was not reported if the reporter considered the cerebration impaired, cognitive disorder and pain to be related to CERVARIX. In around October 2011, postural tachycardia developed. In around February 2013, spastic-like symptoms developed in bilateral lower limbs. In around Summer 2013, the subject experienced difficulty in understanding when reading books. From 20 May 2015 to 17 June 2015, the subject was hospitalized. From 22 July 2015 to 18 August 2015, the subject was hospitalized. As of August 2015, bilateral spastic lower limb and postural tachycardia improved with plasma exchange. The outcome of difficulty in understanding books'' contents, mobile pain, and higher dysfunction was unknown. Other factor: Unknown.


VAERS ID: 609842 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2009-04-27
Submitted: 2015-09-22
   Days after onset:2339
Entered: 2015-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Ataxia, Epilepsy, Fatigue, Hallucination, Hypoaesthesia, Mental disorder, Pain, Pain in extremity, Phobia, Stress
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (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: WAES1509SWE010158

Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number SE-1577272925-E2015-10350) on 18-SEP-2015. Case received from Patient Insurance Company (PIC) on 16-Sep-2015 with case number L15-00523/FJ. The primary reporter was a lawyer. A 15 year-old female patient with no information on medical history provided, had received unspecified dose of GARDASIL (lot number and batch number not reported) via unspecified route of administration in unspecified site of administration on unspecified date and later on 27-Apr-2009 she developed epileptic seizure, pain and ache in leg and arms, numbness in arms, psychological stress, anxiety and concern, hallucinations, ataxia, hypnophobia and tiredness. It was reported from the PIC that they have received a claim from a consumer regarding adverse events after GARDASIL vaccination. The vaccination for the last dose was 15-Oct-2009 (not further specified). Upon medical review the company judged relevant to assess this case as serious due to other medically important event epileptic seizure. At the time of reporting, the outcome was not reported.


VAERS ID: 613254 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-04-16
Onset:2010-11-01
   Days after vaccination:564
Submitted: 2015-09-30
   Days after onset:1794
Entered: 2015-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Anxiety, Appendicitis, Asthenia, Blood test, Depressed mood, Dizziness, Dyspepsia, Endoscopy upper gastrointestinal tract, Fatigue, Gluten sensitivity, Mental disorder, Postural orthostatic tachycardia syndrome, Sigmoidoscopy, Surgery, Syncope, Tilt table test positive
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1509DNK013630

Write-up: Information has been received via Sanofi Pasteur MSD (manufacturer control # E2015-10558) on 25-SEP-2015. Case received from Non-Health Care Professional via Health Authorities on 23-Sep-2015 under the reference number DK-DKMA-ADR 23157841 and DK-DKMA-WBS 0001059. The case is not medically confirmed. The primary reporter was a consumer. A 17-year old female patient (weight: 55kg; height: 172 cm) had received three doses of the GARDASIL, (batch numbers: not reported) via intramuscular route of administration in unspecified site of administration on 29-Oct-2008, not reported date and on 16-Apr-2009. On 01-Nov-2010, she developed dizziness, and later on 01-Feb-2011 she developed fainting. On 01-Oct-2011, she developed tiredness, abdominal pain, digestion problems, gluten intolerance, psychological impact/psychological instability, low energy level, anxiety and depressed mood. On not reported date, she developed POTS. The case is serious due to seriousness criteria hospitalization. The patient has been treated with GUTRON for the adverse reaction POTS. No other medications. HA has requested medical confirmation. Upon medical review, the company judged relevant to code GUTRON as drug used to treat AE. The patient has undergone blood pressure measurement numerous times and has undergone a tilt table test, which gave the diagnosis POTS and treatment with GUTRON. She has taken blood tests in regards to stomach problems. She was operated due to suspicion of appendicitis due to severe abdominal pain. She has been hospitalized once more due to severe abdominal pain without any investigation. She has undergone sigmoidoscopy and gastroscopy to investigate the stomach/bowel problems. She has consulted her physician due to psychological instability, anxiety and depressed mood (not further specified). Upon medical review, the company judged relevant to code operated due to suspicion of appendicitis (onset: not reported, outcome: not reported) as a reaction, as it was mentioned under the Test field in the report, but not coded by HA. No information on other vaccines provided. The patient has not other health issues. At the time of reporting, the patient had not recovered.


VAERS ID: 613654 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-10-06
Entered: 2015-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Blood test normal, Dizziness, Echocardiogram normal, Fatigue, Headache, Mental disorder, Nausea, Nuclear magnetic resonance imaging brain normal, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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 (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood test (??-???-0000): without find a problem. Nuclear magnetic resonance imaging (MRI) (??-???-0000): without finding a problem. Ultrasound scan (??-???-0000): of the heart: without finding a problem.
CDC Split Type: WAES1510DNK000731

Write-up: Information has been received from SPMSD (manufacturer control # E2015-10814) on 01-OCT-2015. Case received from Non-Health Care Professional via Health Authorities on 29-Sep-2015 under the reference number DK-DKMA-ADR 23166377 and DK-DKMA-WBS-0001121. The case is not medically confirmed. The primary reporter was a consumer. A 12-year old female patient (weight: 58 kg; height: 171 cm) had received the first dose of the GARDASIL, (batch number: not reported) via intramuscular route of administration in unspecified site of administration on unspecified date in 2012 and later on unspecified date in 2013, she developed headache, tiredness, nausea, dizziness and abdominal pain. On unspecified date in 2015, she developed fainting and seizures. On not reported date, she developed there has arisen several psychological problems (afraid of seizures and fainting and what they could cause). The patient has not been treated for the adverse reactions. The patient has been hospitalized due to the adverse reactions. The case is serious due to serious criterion hospitalization. No other medications. No information on other vaccines provided. The patient has undergone MRI scan of the head, ultrasound of the heart and blood tests for all known diseases. All without finding a problem (not further specified). No information on medical history provided. At the time of reporting, the patient had not recovered.


VAERS ID: 613963 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-07-24
Onset:0000-00-00
Submitted: 2015-10-14
Entered: 2015-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Alopecia, Arthralgia, Disturbance in attention, Dizziness, Fatigue, Feeling abnormal, Headache, Infection, Limb discomfort, Memory impairment, Mental impairment, Nausea, Palpitations, Photophobia, Speech disorder, Visual impairment
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DK2015144568

Write-up: This case was reported by a consumer via a regulatory authority and described the occurrence of dizziness in a 21-year-old female patient who received CERVARIX (batch number Ukendt, expiry date unknown). Additional patient notes included Patient has no health problems in general. On 24th July 2008, the patient received CERVARIX (intramuscular) 1 dosage form(s). In 2008, an unknown time after receiving CERVARIX, the patient experienced dizziness. On an unknown date, the patient experienced fatigue, headache, nausea, joint pain, infection, concentration impaired, intelligence decreased (serious criteria GSK medically significant), feeling abnormal, short-term memory impairment, photophobia, visual disturbance, speech disorder, heart pounding, leg discomfort and hair loss. On an unknown date, the outcome of the dizziness, fatigue, headache, nausea, joint pain, infection, concentration impaired, intelligence decreased, feeling abnormal, short-term memory impairment, photophobia, visual disturbance, speech disorder, heart pounding, leg discomfort and hair loss were not recovered/not resolved. It was unknown if the reporter considered the dizziness, fatigue, headache, nausea, joint pain, infection, concentration impaired, intelligence decreased, feeling abnormal, short-term memory impairment, photophobia, visual disturbance, speech disorder, heart pounding, leg discomfort and hair loss to be related to CERVARIX. RA Verbatim Text: Adverse Event: dizziness, incredible tiredness, head ache, nausea, joint pain, a lot of infections, concentration difficulty, reporter feels she has lost her "intelligence" reporter feels she is inside a bell all the time, short memory, light sensitivity, blurred vision, speech disorder, palpitations, heavy legs and reporter feels there is hair loss. The patient has not been treated for the adverse event. The patient has not been hospitalized due to the adverse event. Other Medicines: No. Notes: Reporter is getting very nervous about the adverse events, she feels she is getting worse. Especially when she uses her brain or is physically active. Then she experiences nausea and head ache, and must always lie down afterwards, sometimes she sleeps 4-5 hours when she comes home, get''s some dinner and goes to bed again. Comment by Agency: Agency have been in contact with the patient''s own doctor who could not tell the last vaccination date or batch numbers for the vaccines.


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