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Found 247 cases where Vaccine is HPV or HPV2 or HPV4 and Symptom is Mental disability or Mental disorder or Mental disorder due to a general medical condition or Mental impairment or Mental retardation or Mental retardation severity unspecified or Mental status changes

Case Details

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VAERS ID: 482621 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-10-27
Onset:0000-00-00
Submitted: 2013-01-25
Entered: 2013-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Headache, Meningism, Mental disorder, Nuclear magnetic resonance imaging normal, Photophobia
SMQs:, Dementia (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Nuclear magnetic resonance imaging, Normal
CDC Split Type: WAES1201USA04086

Write-up: Case received from a physician on 26-Jan-2012 and medically confirmed. A 15-year-old female patient under oral contraceptive and with no relevant medical history had received the first dose of GARDASIL (batch number not reported) on 27-Oct-2011. Fifteen days after vaccination, the patient developed cephalgia which increased all through November until mid-December. At this date, the patient became intolerable and the patient was hospitalized. Pain were violent but not unilateral. The patient presented with light intolerance. She could no longer read but there was no vomiting. She was put under treatment with opioids for mild to moderate pain (antalgics). She went to see a neurologist who did not find anything particular. MRI was normal. The patient stopped the oral contraceptive but it did not bring any change regarding the cephalgia. After seeking an opinion from a neurologist and a infectious diseases specialist, vaccination was put forward as being the cause. Meningeal irritation was suspected but could not be confirmed as no lumbar puncture was performed. To be noted that the patient''s childhood vaccination had been well tolerated. There was no relevant familial medical history, except for asthma for the father. At the time of reporting, the pain had regressed but the patient was still under treatment with ibuprofen and LAROYXL. Photophobia resolved on an unspecified date. Follow-up information received on 23-Jan-2013: The patient had fully recovered on an unspecified date. Cephalgia lasted for 6 months. Infectious disease specialists considered that events had been induced by vaccination with GARDASIL. At the time of reporting, the patient had psychic disorders which were not related to the events previously reported nor to vaccination.


VAERS ID: 488261 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-03-09
Onset:2013-03-09
   Days after vaccination:0
Submitted: 2013-04-02
   Days after onset:23
Entered: 2013-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NK38610 / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Expired drug administered, Inappropriate schedule of drug administration, Injection site pain, Loss of consciousness, Mental disorder, Mydriasis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1303FRA014449

Write-up: Case of misuse received from a physician and a pharmacist on 11-Mar-2013. Case medically confirmed. A 17-year-old female patient received the second dose of GARDASIL (batch number NP39110, lot number NK38610) on 09-Mar-2013. The patient experienced pain during the injection. After performing vaccination the physician realized that the dose had expired since Apr-2012. The physician informed the patient who then experienced syncope with loss of consciousness, mydriasis and epigastric clonus. The syncope lasted only a few seconds or minutes. The patient recovered. According to the physician these events were likely to be psychological. The patient had received the first dose of GARDASIL (batch number not reported in July 2011. It is noteworthy the timeframe between the first dose and the second one was too long.


VAERS ID: 493509 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-07-01
Onset:0000-00-00
Submitted: 2013-06-06
Entered: 2013-06-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Laboratory test normal, Mental disorder, Pain
SMQs:, Dementia (broad), Arthritis (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: JASMINE; KESTIN
Current Illness:
Preexisting Conditions: Vesicoureteric reflux, Patient medical history of nervosa anorexia, vesicoureteral reflux in childhood and allergy to sulfamide. Anorexia nervosa, Patient medical history of nervosa anorexia, vesicoureteral reflux in childhood and allergy to sulfamide. 03/--/2012, GARDASIL, The patient had received the first dose of GARDASIL (batch number unknown) via intramuscular route in Mar-2012; Contraception; Drug hypersensitivity, Patient medical history of nervosa anorexia, vesicoureteral reflux in childhood and allergy to sulfamide.
Allergies:
Diagnostic Lab Data: Laboratory test (unknown date): normal. Several exams were performed to make a differential diagnosis: -~Rheumatologic exam was normal (no pathology was diagnosed by the rheumatologists) -~Laboratory test were normal -~No fall or recent trauma was reported -~Psychiatric disorder evoked but no evaluation performed.
CDC Split Type: WAES1306FRA000733

Write-up: Case received from the Health Authorities in a foreign country under reference number GR20130236 on 31-May-2013. Case medically confirmed. A 17-year-old female patient had received the second dose of GARDASIL (batch number unknown) via intramuscular route in Jul-2012. About 4 days post-vaccination, she experienced arthralgia (mechanical-like pain) in both hips and sacroiliac joints. Pain was constant and worsened at exertion. The patient had had several corrective treatments: level 1 analgesic, NSAID''s, corticosteroid and weak opiods. Several exams were performed to make a differential diagnosis: -Rheumatologic exam was normal (no pathology was diagnosed by rheumatologist) -Laboratory tests were normal -No fall or recent trauma was reported -Psychiatric disorder evoked but no evaluation performed. At the time of reporting, the patient still experienced pain and was treated with LAMALINE. The patient had received the first dose of GARDASIL (batch number unknown) via intramuscular route in Mar-2012. Her medical history included nervosa anorexia, vesicoureteral reflux in childhood and allergy to sulfamide. At the time of reporting, the patient was taking oral contraceptive, JASMINELLE and KESTIN. Family medical history included spondylitis in the patient''s father. The patient had received concomitantly a dose of VAXIGRIP (batch number not reported)on 27-Dec-2012. The Health Authorities searched the literature regarding duration of arthralgia after vaccination and only limited information was available. However, pain seemed to regress after few days/months with anti-inflammatory. Therefore, according to the Health Authorities, arthralgia could only be slightly ascribed to the vaccine. Considering the symptom''s length and family medical history of the patient, chronic inflammatory disease could not be ruled out. Considering the patient''s medical history, psychiatric disorder could not be ruled out. At the time of reporting, the patient had not recovered. Upon medical review the company judged relevant to code the adverse event: "suspicion of psychiatric disorder" which was mentioned by the CA in the narrative but not coded. The Health Authorities assessed the causal relationship between the reported reaction (s) and vaccination as doubtful (C1 S1 I1) according to the Foreign method of assessment.


VAERS ID: 493736 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-03-19
Onset:2012-05-01
   Days after vaccination:43
Submitted: 2013-06-07
   Days after onset:402
Entered: 2013-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Convulsion, Gait disturbance, Mental disorder, Pain in extremity, Walking aid user
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? Yes
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: WAES1306JPN000342

Write-up: Initial information has been received from a physician concerning a 14 year old female patient who on 19-MAR-2012 was placed on therapy with HPV4 injection drug, 0.5 ml once a day (the third time). Suspect therapy included HPV injection drug 0.5 ml once a day started on 30-SEP-2011 (the first time), HPV4 injection drug, 0.5 ml once a day (duration not reported) (the second time). There was no concomitant medication. In MAY-2012 (about two months after inoculating HPV4 vaccine), foot pain appeared, the patient developed feelings of weakness in feet and gait disturbance. Sometimes the patient developed convulsion. In MAY-2012, the patient went to A hospital, but the etiology of disease could not been confirmed. The patient was diagnosed with adolescent mental disorder. At the time of the report, the patient still walked on crutches. The patient had not recovered from feelings of weakness in feet and gait disturbance. The outcome of convulsion and adolescent mental disorder was unknown. Reporter comment: after reading the adverse event report of HPV vaccine, the guardian went to the hospital at the end of MAY-2013 where the patient got vaccinated before and discussed whether the adverse event was caused by the vaccine or not. The adverse event in the report was caused by CERVARIX, so if HPV4 could also cause the adverse event, the relationship in this case maybe exist. However, although the patient went to a hospital immediately to take a careful examination when the adverse event appeared, it was still unclear that the adverse event was caused by the vaccine due to inadequate information. The reporting physician did not assess the relationship of feelings of weakness in feet, gait disturbance, convulsion, adolescent mental disorder to HPV4. The reporting physician considered that the feeling of weakness in feet and the gait disturbance were serious due to disabling. The reporting physician did not assess the seriousness of the convulsion and the adolescent mental disorder. Upon internal review, the convulsion was determined to be serious as an other important medical event. Additional information has been requested.


VAERS ID: 497405 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-07-01
Onset:0000-00-00
Submitted: 2013-07-22
Entered: 2013-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Abulia, Arthralgia, Back pain, Chest pain, Decreased appetite, Depressed level of consciousness, Depression, Dermatitis, Diarrhoea, Dizziness, Dyspnoea exertional, Headache, Hypersomnia, Hyperventilation, Injection site swelling, Malaise, Mental impairment, Oedema peripheral, Pain in extremity, Palpitations, Parotitis, Pyrexia, Stomatitis, Urticaria, Vaccine positive rechallenge, Vomiting
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0908384A

Write-up: This case was reported by a physician and described the occurrence of swelling injection site in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In July 2011, the subject received 1st dose of CERVARIX (intramuscular, unknown injection site and batch number). One week after the first vaccination, the subject experienced injection site swelling, pyrexia, headache, and urticaria. The symptoms subsided in approximately 1 week, but headache and urticaria lasted 2 weeks. In October 2011, the subject received 2nd dose of CERVARIX (intramuscular, unknown injection site and batch number). Within one month after 2nd dose of vaccine, the subject experienced the same symptoms as those after the first vaccination except urticaria. She also experienced malaise. One month after the second vaccination, the subject also experienced stomatitis, pyrexia, diarrhoea, abdominal pain, and dermatitis developed, and 2 months after vaccination, severe urticaria developed. In March 2012, the subject received 2nd dose of CERVARIX (intramuscular, unknown injection site and batch number). One week after the third vaccination, the subject experienced arthralgia along with the same symptoms as those experienced after the second vaccination. Fourteen days after the vaccination, exertional dyspnoea and severe malaise were also developed. One month and a half after the vaccination, urticaria, pain in the lower and upper extremities, dermatitis, and stomatitis developed. Stomatitis, dermatitis, malaise, low back pain, slight fever, arthralgia, abdominal pain, and headache were developed and lasted for 2 or 3 months after vaccination. Hyperpnoea and a feeling of dyspnoea were also experienced even at rest as well as pedal oedema. Three to five months after the third vaccination, the subject experienced generalised joint pains, abdominal pain, headache, multiple stomatitis, inappetence, vomiting, slight fever, and parotitis. Six to nine months after the third vaccination, she experienced abnormal malaise, clouding of consciousness, anterior chest pain similar to angina pectoris and palpitations also developed. In addition, giddiness and excessive sleep were developed. The physician considered the events were clinically significant (or requiring intervention). Approximately 10 months after the third vaccination, the chest pain was resolved but replaced by hyperpnoea. Although the pain in the body improved, the subject still experienced fatigue, hypobulia, and reduced thinking. It was considered that the subject had depressive symptoms. The outcome of the rest of the events was unspecified.


VAERS ID: 500212 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-06-12
Onset:2013-06-26
   Days after vaccination:14
Submitted: 2013-08-22
   Days after onset:57
Entered: 2013-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H016574 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Computerised tomogram head abnormal, Confusional state, Depressed mood, Disturbance in attention, Dizziness, Impaired work ability, Libido decreased, Mental status changes, Musculoskeletal disorder, Myalgia, Nausea, Speech disorder, Stress, Transient ischaemic attack
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), 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? 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: CT (cerebral) was performed on an unspecified date with nothing abnormal as result.
CDC Split Type: WAES1308DNK009746

Write-up: Case received from a health care professional via the Health Authorities in a foreign country on 15-Aug-2013 under the reference number DK-DKMA-ADR 22208286 and DK-DKMA-EFO6541. Case medically confirmed. A 42 year old female patient (height 174 cm, weight 85 kilogram) had received an injection of GARDASIL (dose 2, batch number H016574, intramuscular route, site of administration not reported) on 12-Jun-2013 and later on 26-Jun-2013 (i.e. 14 days p-v) she developed Transient Cerebral Ischaemia (TCI), difficulty speaking and difficulty controlling right arm and leg. The patient was hospitalized due to the events. CT (cerebral) was performed on an unspecified date with nothing abnormal as a result. The patient''s medical history includes: First GARDASIL vaccination (dose 1, batch number not reported, site and route of administration not reported) on 06-Mar-2013. Previously healthy patient. At the time of reporting, the outcome was unknown. Additional information received from health authority on 19-Aug-2013. Additional reference number received: DK-DKMA-ADR 22213488 and DK-DKMA-EFO6584. HA received information from the patient. Patient initials, height: 165 cm, weight 89 kilogram updated and changed. According to the patient, she developed speech impairment, confusion, dizziness, nausea, concentration impaired, TCI/blood clots, tiredness, tender muscles, mentally unstable, anxiety, sadness, quickly stress, decreased sex drive. Due to these symptoms the patient was absent from work for 5 weeks and had to start seeing a psychologist. She is very sad all the time. The patient received the following treatment for the side effect: clopidogrel (other MFR) and simvastatin (other MFR). HA added AE with outcome and onset as follows: quickly stress: unknown (onset not reported), sadness: unknown (onset not reported), anxiety: unknown (onset not reported), decreased sex drive: unknown (onset not reported), confusion: not recovered (onset 26-Jun-2013), concentration impaired: not recovered (onset 26-Jun-2013), tender muscles: unknown (onset not reported), mentally unstable: unknown (onset not reported), dizziness: not recovered (onset 26-Jun-2013), tiredness: unknown (onset not reported), nausea: not recovered (onset 26-Jun-2013).


VAERS ID: 503433 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-03-15
Onset:0000-00-00
Submitted: 2013-09-20
Entered: 2013-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Mental disorder
SMQs:, Dementia (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: FYBOGEL; SANOMIGRAN; Terbinafine; TETRALYSAL
Current Illness: Dermatillomania; Immunisation; Irritable bowel syndrome; Headache; Fungal infection; Acne
Preexisting Conditions: Impetigo; 10/06/2010, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309IRL007357

Write-up: This case was received from the health authority on 10-Sep-2013. IMB ref 2013-018105. This case is medically confirmed as it was reported by a general practitioner. A 17 year old female patient, with a medical history of dermatillomania which is continuing and impetigo, received on 02-Dec-2010 a second dose of GARDASIL, (batch number not reported) intramuscularly, site of administration not reported and on 25-Feb-2010, an injection of PANDEMRIX, (batch number not reported) intramuscularly, dose number and site of administration not reported. The patient has since developed fatigue and has missed a lot of school. The fatigue was initially noted in Jan-2011. The patient has no symptoms of narcolepsy. The reporter indicated that she is not sure of the cause of the patient''s fatigue. The reporter got a second opinion and it was felt the reaction to be more psychological. It was reported the patient previously received the first dose of GARDASIL (batch number not reported), intramuscularly on 06-Oct-2010 and a third dose on 15-Mar-2011. The patient was concomitantly treated with FYBOGEL Citrus (Ispaghula husk) 1 tablet daily orally and mebeverine HCL (generic) orally since 10-Oct-2011 for irritable bowel syndrome, SANOMIGRAN (pizotifen) 1.5 mg daily orally since 06-Jan-2012 for headache, terbinafine (generic) 250 mg daily for fungal infection since 13-Apr-2012 and with TETRALYSAL (lymecycline) 300 mg daily orally for acne from 02-Jul-2012 to 17-Jan-2013. The reporter indicated that the patient has been prescribed various medications over the last few years for headaches and irritable bowel syndrome but the reporter is unsure if the patient took them. (As no information was provided on the onset for the events, the Company matched the IMB report regarding the coded AE). Upon internal review the Company judged relevant to code "reaction to be more psychological", LLT: psychological disorder NOS. At the time of reporting, the patient was recovering from fatigue. The IMB considered that case serious due to be medically significant.


VAERS ID: 506357 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-09-15
Onset:2012-09-15
   Days after vaccination:0
Submitted: 2013-10-03
   Days after onset:383
Entered: 2013-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H007797 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Gait disturbance, Mental disorder, Muscle spasms, Pain, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (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:
CDC Split Type: WAES1310DNK001354

Write-up: Case received from non-health professional via Health Authorities on 26-Sep-2013 under the reference numbers 22252694 and 13-6626 (patient insurance company). The primary reporter was a lawyer from patient insurance company. Case is not medically confirmed. A 20 year old female patient, developed on 15-Sep-2012 sensory disturbance, cramps, unsteady walking mode and pain in association with the cramps, after she had received primary injection of GARDASIL (batch and lot number H007797) via not reported route and in not reported site of administration on 15-Sep-2013. HA: Case received on 17-Sep-2013 from the patient insurance company J. no. 13-6626 in terms of the patient''s initial notification. Note that the patient insurance company has not taken a decision on the matter yet. Adverse reactions: Cramping and pain associated with the cramps, sensory disturbance in both legs and feet and unsteady walking mode. Description of the adverse reactions: The patient cannot run anymore and feel that the adverse reactions have had major psychological consequences. The patient is undiagnosed despite hospitalizations and various examinations. The patient has received medical treatment for the adverse reactions (she has not reported which). Physician''s vaccination service informs the on 26-Sep-2013 that first vaccination was given on 15-Sep-2012 has the batch number H007797 and second vaccination given on 10-Nov-2012 have the same batch number as the first vaccination i.e. H007797 and number H007797 and second vaccination given on 10-Nov-2012 have the same batch number as the first vaccination i.e. H007797 and the third vaccination given on the 12-Mar-2013 has the batch and lot number J000160, exp. 30-JUN-2015. No information on medical history reported. At the time of reporting, the outcome was not recovered.


VAERS ID: 506578 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-01-26
Onset:2012-02-02
   Days after vaccination:7
Submitted: 2013-10-07
   Days after onset:612
Entered: 2013-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Blood test normal, Malaise, Mental impairment, Schizophrenia, Somnolence, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood test, 02Feb2012, no abnormality
CDC Split Type: B0925815A

Write-up: This case was reported by a physician via a regulatory authority (V13000667) and described the occurrence of schizophrenia in a 17-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline) and LEXOTAN (non-gsk). Historic vaccination included 1st and 2nd dose of CERVARIX (GlaxoSmithKline) given on an unspecified date. On 26 January 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). On 2 February 2012, 7 days after vaccination with CERVARIX, the subject experienced abdominal pain and vomiting. On unknown date in 2012, as the symptoms persisted, the subject visited an unknown hospital where she was treated with Bio-Three, CEREKINON and LEXOTAN. On an unknown date, abdominal pain was improved but sleepiness, malaise and reduced thinking appeared. The subject received LEXOTAN for 1 or 2 weeks. The subject''s mother was informed regarding effects of LEXOTAN and was anxious. On unknown date after treatment with LEXOTAN was discontinued, sleepiness, malaise and reduced thinking persisted. On 19 June 2012, the subject visited the department of psychiatry at hospital A. The subject was diagnosed with schizophrenia and was prescribed neuroleptic (Anti-psychotic medication) medicine. On 20 September 2013, the subject was attending hospital A for treatment. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting, schizophrenia, thinking reduced were unresolved and abdominal pain was improved. The outcome of other events was unknown. The causal relationship to CERVARIX was unknown.


VAERS ID: 508908 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-03-06
Onset:2012-03-06
   Days after vaccination:0
Submitted: 2013-10-22
   Days after onset:594
Entered: 2013-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Disturbance in attention, Dizziness, Injection site pain, Malaise, Mental impairment, Nasopharyngitis, Nausea, Urticaria
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0931152A

Write-up: This case was reported by a physician and described the occurrence of thinking reduced in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Historic vaccination included 1st and 2nd dose of CERVARIX (.5 ml, intramuscular; unknown site of injection and batch number) given in 2011. On 6 March 2012, the subject received 3rd dose of CERVARIX (.5 ml, intramuscular, unknown site of injection at the left side and batch number). On 6 March 2012, during vaccination with CERVARIX, the subject experienced injection site pain. One year after the vaccination with the third dose of CERVARIX, the subject presented with common cold and visited the hospital. On 3 October 2013, the subject presented with urticaria and visited the hospital. On 10 October 2013, the subject visited the hospital and presented with giddiness and malaise. On 11 October 2013, the subject presented with the giddiness and queasy. Furthermore, the subject recently complaint that she was not able to concentrate on her study and her academic performance had declined (reduced thinking). The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. The physician considered that urticaria was unrelated to vaccination with CERVARIX.


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