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Case Details (Sorted by Age)

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VAERS ID:317871 (history)  Vaccinated:2008-03-18
Age:16.0  Onset:2008-04-12, Days after vaccination: 25
Gender:Female  Submitted:2008-06-27, Days after onset: 76
Location:Foreign  Entered:2008-06-30, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: cerebrospinal MRI performed on 2-MAY-2008: area of hypersignals=presence of an active demyelination at brain level spatial dissemination with some positive lesions at gadolinium and some negative lesions at gadolinium as well
CDC Split Type: WAES0806USA08511
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Demyelination, Eye disorder, Fatigue, Hypoacusis, Lumbar puncture, Multiple sclerosis, Nuclear magnetic resonance imaging abnormal, Paraesthesia, Sensorimotor disorder
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Optic nerve disorders (broad), Demyelination (narrow), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (narrow)
Write-up: Information has been received from a general practitioner concerning a 16 year old female who on 18-MAR-2008 was vaccinated with GARDASIL (batch number, route and site, not reported). It was reported by a general practitioner to a company sales representative that a 16 year-old female patient received a dose of GARDASIL, on an unspecified date. 3 weeks post-vaccination the patient consulted neurologist for suspicion of multiple sclerosis. Additional information received on 22-JUN-2008: A 16-year-old female patient with neither relevant medical history nor familiar medical history reported received the first dose of GARDASIL (batch number, route and site, not reported) on 18-MAR-2008. Route of administration and site of injection were not reported. Around the 12 to 19-APR-2008 i.e. approximately 3 weeks after vaccination the patient experienced sensorimonitor disorder, with paraesthesia of lower limbs, hypoacusis, important fatigue and ocular troubles. On 23-Apr-2008 a neurologist requested cerebrospinal MRI performed on 2-MAY-2008 and which revealed an area of hypersignals evocating the presence of an active demyelination at brain level. There was spatial dissemination with some positive lesions at gadolinium fluid proteins at 0.28 g/L, glycorrhachia at 3.24 mm/L. Electrophoresis was on-going. Diagnosis was multiple sclerosis. The patient recovered from the symptoms above mentioned. Multiple sclerosis was considered to be an other important medical event. Other business partner numbers include E2008-05797. No further information is available.

VAERS ID:318100 (history)  Vaccinated:2007-06-14
Age:16.0  Onset:2007-09-04, Days after vaccination: 82
Gender:Female  Submitted:2008-07-01, Days after onset: 301
Location:Foreign  Entered:2008-07-02, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806AUS00133
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Agitation, Ataxia, Confusional state, Encephalitis, Endotracheal intubation, Intensive care, Leukoencephalomyelitis
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Demyelination (narrow)
Write-up: Information was obtained on request by the Company from the agency via a Case Line Listing and Public Case Detail Form concerning a 16 year old female who on 14-MAY-2007 and 14-JUN-2007 was vaccinated with the first and second dose of GARDASIL. On 04-SEP-2007, 113 days after the first vaccination and 82 days after the second vaccination, the patient experienced encephalitis, agitation, ataxia and confusional state, also reported as acute disseminated encephalomyelitis. The patient presented to the hospital on 08-SEP-2007 with agitation, confusion and ataxia. The patient was treated in the intensive care unit, intubated and ventilated and was given methylprednisolone. At the time of reporting on 20-NOV-2007, the patient''s encephalitis, agitation, ataxia and confusional state persisted. The agency considered that encephalitis, agitation, ataxia and confusional state were possibly related to therapy with GARDASIL. The original reporting source was not provided. Subsequently the patient''s experience was reported in an article. Additional information is not expected.

VAERS ID:318164 (history)  Vaccinated:2008-05-30
Age:16.0  Onset:2008-05-30, Days after vaccination: 0
Gender:Female  Submitted:2008-07-02, Days after onset: 33
Location:Foreign  Entered:2008-07-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin trihydrate
Current Illness: Cough
Preexisting Conditions: Epidemic parotitis; hyperpyrexia; lipothymia; varicella.
Diagnostic Lab Data: UNK
CDC Split Type: B0524347A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B024DH IMRA
Administered by: Other     Purchased by: Other
Symptoms: Cold sweat, Fall, Loss of consciousness, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of loss of consciousness in a 16-year-old female subject who was vaccinated with BOOSTRIX, GlaxoSmithKline. The subject''s medical history included varicella, epidemic parotitis and lipothymia in 2003 after hyperpyrexia. Concurrent medical conditions included catarrhal cough (1 week before vaccination treated with Amoxicillin). On 30 May 2008, the subject received 1st dose of BOOSTRIX (intramuscular, unknown injection site). On 30 May 2008, less than one day after vaccination with BOOSTRIX, the subject experienced lipothymia. The action taken was raising lower limbs. On 30 May 2008, the event was resolved. The regulatory authority reported that the event was possibly related to vaccination with BOOSTRIX. No additional information expected. The case has been closed. Follow up information received on 26 June 2008: On 30 May 2008, the subject received 1st dose of BOOSTRIX (intramuscular, unknown injection site). On 30 May 2008, few minutes after vaccination with BOOSTRIX, the subject lost consciousness and fell. She showed pale skin and cold sweating. The subject regained consciousness few seconds later, spontaneously. This case was assessed as medically serious by GSK.

VAERS ID:318264 (history)  Vaccinated:2008-05-30
Age:16.0  Onset:2008-05-31, Days after vaccination: 1
Gender:Female  Submitted:2008-07-02, Days after onset: 32
Location:Foreign  Entered:2008-07-07, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0806USA07985
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTIPV: DT + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Mass, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad)
Write-up: Information has been received from a physician concerning a 16 year old female who on 30-MAY-2008, was vaccinated with the first dose of GARDASIL and a dose of DT-IPV in the shoulder. Batch number and routes were not reported. In the morning of 31-MAY-2008, the patient had fever between 40 and 41 degrees C and muscle soreness. The patient was directed to hospital where she was under observation at emergency room. On the evening of the same day, she left the hospital. According to the emergency department, the reaction was to GARDASIL. The patient fully recovered in two days. On 11-JUN-2008, the physician observed a "mass" on each wrist which seemed to be cyst although that it presented abnormal osseous excrescence reported as rigid, remain fixed and were painful. The events appeared a week after the vaccination. A work up was scheduled. At the time of the report, the patient was not recovered. Fever and muscle soreness have been reported following both DT-IPV and human papillomavirus vaccines. Time to onset, clinical feature and quick recovery are consistent with the role of the vaccines. No conclusion can be drawn regarding the mass on each wrist that appeared one week after vaccination as neither results of investigations nor final diagnosis are available. Another etiology can therefore not be ruled out. Other business partner numbers included: E2008-05572. The fever, muscle soreness and pain were considered to be other medically important conditions.

VAERS ID:318278 (history)  Vaccinated:2008-01-24
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-03
Location:Foreign  Entered:2008-07-07, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Breast operation
Diagnostic Lab Data: ophthalmological exam, Normal; electroencephalography, Normal; magnetic resonance imaging, Normal; ultrasound, Normal; spinal X-ray, Normal; diagnostic laboratory test, Normal
CDC Split Type: WAES0806USA08646
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0352U1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diplopia, Dizziness, Electroencephalogram normal, Hypoaesthesia, Laboratory test normal, Neck pain, Nuclear magnetic resonance imaging normal, Ophthalmological examination normal, Spinal X-ray normal, Ultrasound scan normal, Vision blurred
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Ocular motility disorders (broad), Arthritis (broad)
Write-up: Information has been received from a general practitioner concerning a 16 year old female with history of breast surgery in March 2008, who on 28-NOV-2007 was vaccinated with the first dose of GARDASIL (Lot # 0276U; batch NF58550) which was well tolerated. On 24-JAN-2008, the patient was vaccinated with the second dose of GARDASIL (Lot # 0352U; batch NG00320). Since January 2008, the patient experienced recurrent neck pain with dizziness, numbness of the skin and double/blurred vision. In the course she presented to a chiropractor once. After "setting maneuver" symptoms improved for short time. She was hospitalized for diagnostics from 11-APR-2008 to 17-APR-2008. All examinations including ophthalmologic check up, electroencephalography (EEG), cranial magnetic resonance imaging (MRI), sonography, X-ray of cervical spine and routine laboratory test showed normal results. Treatment was carried out with analgesics (not specified), ruby light and massage and lead to slow improvement. A psychogenic cause for the complaints was assumed. At the time of the report she had not yet completely recovered. Other business partner numbers included: E2008-05737. Additional information has been requested.

VAERS ID:318723 (history)  Vaccinated:0000-00-00
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-10
Location:Foreign  Entered:2008-07-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807AUS00066
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Gait disturbance, Malaise
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad)
Write-up: Information has been received in a newspaper article, 06-JUL-2008, received from a mother of a 16 year old female who in 2007 ("last year") was vaccinated with the first dose of GARDASIL. In 2007 the patient felt sick after her first dose of GARDASIL. It was also reported that the patient could hardly walk after the third dose of GARDASIL. The patient''s mother took her to three hospitals in a bid to find out what was wrong with her but she could not confirm whether the cause of her daughter''s illness was definitely the GARDASIL as it had emerged at the same time. Upon internal medical review, "could hardly walk after the third" was considered to be disabling. Additional information is not expected.

VAERS ID:318725 (history)  Vaccinated:0000-00-00
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-10
Location:Foreign  Entered:2008-07-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807AUS00068
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abasia, Activities of daily living impaired, Anorexia, Asthenia, Influenza like illness, Malaise, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad)
Write-up: Information has been received in a newspaper article, 06-JUL-2008, and also on the news (Sunday - 06-JUL-2008) received concerning a 16 year old female who was vaccinated with GARDASIL. Subsequently the patient felt a bit off after the first two doses of GARDASIL but did not think anything of it. The patient reported that she missed the fourth term of school in 2007 after becoming so ill that she was unable to get out of bed. The patient''s mother reported that after her daughter received her third dose of GARDASIL she started getting flu-like symptoms and it went downhill. The patient lost her appetite, dropping 5 kg and 8 kg and got so weak that she couldn''t walk unaided. Upon internal medical review, "dropping 5 kg and 8 kg and got so weak that she couldn''t walk unaided" was considered to be disabling. Additional information is not expected.

VAERS ID:318728 (history)  Vaccinated:2007-09-10
Age:16.0  Onset:2007-12-10, Days after vaccination: 91
Gender:Female  Submitted:2008-07-10, Days after onset: 212
Location:Foreign  Entered:2008-07-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: hormonal contraceptives (unspecified)
Current Illness: Migraine
Preexisting Conditions:
Diagnostic Lab Data: electroencephalography, 22Jan08, intermittent focal disorder right pariental; no typical epileptic activity; electrocardiogram, 26Feb08, "prolonged ECG" normal result; abdominal ultrasound, normal results; electroencephalography, Prolonged
CDC Split Type: WAES0807USA00973
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea, Dizziness, Ear, nose and throat examination normal, Electrocardiogram normal, Electroencephalogram abnormal, Epilepsy, Loss of consciousness, Night sweats, Nuclear magnetic resonance imaging brain normal, Ophthalmological examination normal, Syncope vasovagal, Ultrasound abdomen normal, Ultrasound thyroid normal, Visual evoked potentials normal, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (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), Convulsions (narrow), Pseudomembranous colitis (broad), 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), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a gynecologist concerning a 16 year old female with migraine headaches and without family history of epilepsy who on 10-SEP-2007 was vaccinated IM with a first dose of GARDASIL in the upper arm. Concomitant therapy included hormonal contraceptives (unspecified) (manufacturer unknown) for systemic use. On 10-DEC-2007 the patient suddenly developed unconsciousness for several hours in the morning. Additionally, she experienced persisting dizziness and diarrhea for several weeks as well as night sweats and loss of weight. In the time following the events the unconsciousness reoccurred. The patient was hospitalized from 21-JAN-2008 to 23-JAN-2008, 27-JAN-2008 to 28-JAN-2008, 28-FEB-2008 to 04-MAR-2008 and from 01-APR-2008 to 04-APR-2008. On 09-JAN-2008 the patient had and ear, nose and throat examination which showed normal results. The patient had abdominal and thyroid sonography and cranial magnetic resonance imaging which showed normal results. An ophthalmologic examination was normal as well as visual evoked potentials. On 22-JAN-2008, electroencephalogram (EEG) showed intermittent focal disorder right parietal, but no typical epileptic activity was detected. On 28-FEB-2008 the patient had a "prolonged electrocardiograph" which showed normal results. A prolonged-Video-EEG was normal. In a control on 29-FEB-2008 and on 25-MAR-2008 no focal disorder was detected. Differential diagnosis were epilepsy and syncope. The neurological department of the university favoured vasovagal syncopes, but a final diagnosis could not be established. At the time of the report, the outcomes of the syncope vasovagal, epilepsy, unconsciousness, dizziness, diarrhea, night sweats and loss of weight were unknown. Other business partner numbers included: E2008-06028. Additional information is not expected. This case is closed.

VAERS ID:318814 (history)  Vaccinated:2007-12-20
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-11
Location:Foreign  Entered:2008-07-14, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Immunisation
Diagnostic Lab Data: electrocardiogram, normal results; electroencephalography, normal result; pulmonary function test, normal result; ears, nose, and throat examination, normal result; arterial blood O2 saturation
CDC Split Type: WAES0807USA00976
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0352U2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Ear, nose and throat examination normal, Electrocardiogram normal, Electroencephalogram normal, No reaction on previous exposure to drug, Oxygen saturation normal, Pulmonary function test normal, Sensation of foreign body
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: Information has been received from a health agency concerning a 16 year old female who on 20-DEC-2007 was vaccinated with a third dose of GARDASIL (lot # 0352U, batch # NG00320). In December 2007, the patient experienced dyspnoea of unknown origin and a globus feeling of the throat. She was hospitalized on an unspecified date. Electrocardiogram, electroencephalography, pulmonary function test, arterial blood oxygen saturation test and ears, nose, and throat examination showed all normal results. The adverse events were ongoing at the time of reporting. The patient was vaccinated with a first dose of GARDASIL (lot # 655671/1024U, batch # NE51780) on 28-JUN-2007 and a second dose of GARDASIL (lot # 1473F, batch # NF46730) on 23-AUG-2007. No adverse effects occurred. It was pointed out by the reporter that patient informed herself in the internet about HPV vaccination and possible side effects and only than reported the events to the physician. Other business partner numbers included E2008-06194. No further information is available.

VAERS ID:318980 (history)  Vaccinated:2008-04-22
Age:16.0  Onset:2008-04-28, Days after vaccination: 6
Gender:Female  Submitted:2008-07-14, Days after onset: 77
Location:Foreign  Entered:2008-07-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: radionuclear scan, 28Apr08, Basedow''s disease and hyperthyroidy; serum antithyroglobuin antibody, 06May08, 8987; serum antithyroid peroxidase antibody, 06May08, 94; total serum thyroxine, 06May08, 38.5; total serum triiodothyronine test, 06
CDC Split Type: WAES0807USA01407
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anti-thyroid antibody positive, Antibody test positive, Basedow's disease, Diagnostic procedure, Thyroxine increased, Tri-iodothyronine increased
SMQs:, Optic nerve disorders (broad), Hypothyroidism (broad), Hyperthyroidism (narrow), Vasculitis (broad), Hypersensitivity (broad)
Write-up: Information has been received from the health authority concerning a 16 year old female who on 22-APR-2008 was vaccinated with a dose of GARDASIL (batch # not reported). On 28-APR-2008, clinical diagnosis was established during consultation and the scintigraphy confirmed basedow''s disease. The patient was treated with NEO-MERCAZOLE and was under observation. On 06-MAY-2008 biological values showed: T4L 38.5 (N=<18) - anti-Tg antibodies (thyroglobulin) 8987 (N=<50); T3L 19.6 (N=<3.8) - anti-TPO antibodies (thyroid peroxidises) 94 (N=<60). At the time of the report, the patient did not recover. The reporter considered basedow''s disease to be an other important medical event. Other business partner numbers included: E2008-06317 and CF20080290. No further information is available.

VAERS ID:318981 (history)  Vaccinated:2008-05-16
Age:16.0  Onset:2008-05-16, Days after vaccination: 0
Gender:Female  Submitted:2008-07-14, Days after onset: 59
Location:Foreign  Entered:2008-07-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Appendicectomy
Diagnostic Lab Data: electromyography, normal; magnetic resonance imaging, normal
CDC Split Type: WAES0807USA01409
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dysgraphia, Electromyogram normal, Headache, Hypoaesthesia, Injected limb mobility decreased, Muscle spasms, Nausea, Nuclear magnetic resonance imaging normal, Paraesthesia, Paresis, Sensorimotor disorder, Skin warm
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Information has been received from health authorities concerning a 16 year old female patient with a history of appendicectomy who on 16-MAY-2008 was vaccinated with a second dose of GARDASIL (batch number not reported) in the right arm, via intramuscular route. Shortly after vaccination, occurred nausea and headache which resolved spontaneously within a few hours. Two days after occurred paresis and hypoesthesia of the right upper limb where the vaccination was performed. Following the twenty four hours sensitomotor deficiency increased with impossibility to mobilise the right arm, important hypoesthesia for warmth, pain and touch. Only a deep pressure was observed. Ten days later, deficiency started to resolve with still the inability to write. There was also paresthesia type of electric shock and muscular spasms. Electromyography was normal as MRI. On 10-JUN-2008, the patient was recovering from motor and sensitive but there was a presence of hypoesthesia especially at forearm. On 23-JUN-2008 the patient used her arm normally and did not complain anymore. The reporter considered hypoesthesia, paresthesia, muscular spasm, paresis, nausea, headache, mobility decreased and sensorimotor disorder to be disabling. Additional information was not available. Other business partners included are: E2008-06346.

VAERS ID:319299 (history)  Vaccinated:0000-00-00
Age:16.0  Onset:2008-06-24
Gender:Female  Submitted:2008-07-15, Days after onset: 21
Location:Foreign  Entered:2008-07-16, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807USA01420
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blindness, Optic neuritis, Visual field defect
SMQs:, Noninfectious encephalitis (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Retinal disorders (broad), Ocular infections (broad)
Write-up: Information has been received from a health professional concerning a 16 year old female with no medical record or family history of eye illness who in late May 2008 or the beginning of June 2008 (exact date not reported) was vaccinated with the second dose of GARDASIL (batch number, site and route not reported). On 24-JUN-2008 the patient suffered a sudden loss of vision in the left eye, bilateral neuritis and defective visual field in both eyes. On 30-JUN-2008, the patient was admitted into the hospital. She is currently still hospitalized and is being treated with corticoids. The patient''s symptoms persisted. Other business partner number included: E2008-06263. Additional information has been requested.

VAERS ID:320290 (history)  Vaccinated:2008-07-10
Age:16.0  Onset:2008-07-10, Days after vaccination: 0
Gender:Female  Submitted:2008-07-23, Days after onset: 13
Location:Foreign  Entered:2008-07-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Convulsion
Diagnostic Lab Data: UNK
CDC Split Type: D0058029A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB404BB3IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB177AD0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Loss of consciousness, No reaction on previous exposure to drug, Syncope
SMQs:, Torsade de pointes/QT prolongation (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), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a physician and described the occurrence of convulsive syncope in a 16-year-old female subject who was vaccinated with HAVRIX 1440 (GlaxoSmithKline), ENGERIX B adult. At an unspecified time after vaccination with ENGERIX B and HAVRIX, the subject experienced convulsion. This case was assessed as medically serious by GSK. Follow-up information was received on 21 July 2008. Previous vaccination with ENGERIX B was well tolerated. On 10 July 2008 the subject received 1st dose of HAVRIX 1440 (intramuscular, right deltoid), 4th dose of ENGERIX B adult (intramuscular, left deltoid). On 10 July 2008, 1 minute after vaccination with ENGERIX B adult and HAVRIX 1440, the subject experienced convulsive episode. At the time of reporting the events were resolved. The vaccination course with HAVRIX 1440 and ENGERIX B adult was discontinued. The physician considered the event was certainly related to vaccination with HAVRIX 1440 and ENGERIX B adult. The physician provided the targeted follow-up questionnaire. The subject''s medical history included seizures (including febrile seizures and epilepsy). None of the following events was known in medical history: movement disorders, other CNS conditions, head injury, cerebral palsy, neurological handicap or congenital abnormality, diabetes mellitus, renal failure, alcohol or drug abuse. The patient has not received medication which is known to reduce the seizure threshold. Four weeks before the event an electroencephalogram (EEG) was without pathologic findings. The convulsion was witnessed. The event was not preceded by an aura or headache. The symptoms were limited to head and arms. The patient did lose consciousness. Upon regaining consciousness the patient was not disoriented or drowsy. The patient could remember the event. The patient did not experience urine/fecal incontinence. There was no evidence that the symptoms may have resulted from withdrawal of alcohol or other psychotropic substances. Follow-up of the event was not planne

VAERS ID:321008 (history)  Vaccinated:2007-08-27
Age:16.0  Onset:2008-02-20, Days after vaccination: 177
Gender:Female  Submitted:2008-07-31, Days after onset: 161
Location:Foreign  Entered:2008-08-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Paraesthesia
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807AUS00277
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0734U2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Central nervous system lesion, Headache, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Information was obtained on request by the Company from the agency via a Public Case Detail Form concerning a 16 year old female with a history of vague episode of paraesthesia (2004) who on 27-AUG-2007 was vaccinated with the first dose of GARDASIL (Lot No. 655743/0313U, Batch No. J1022, Expiry date, 08-AUG-2009). On 25-OCT-2007, she was vaccinated with the second dose of GARDASIL (Lot No. 657874/0582U, Batch No. J2299, Expiry date 26-FEB-2010). On approximately 18-FEB-2008, she was vaccinated with the third dose of GARDASIL (Lot No. 658214/0734U, Batch No. J2895, Expiry date 13-MAR-2010). On 20-FEB-2008 the patient experienced headache, central nervous system lesion and paraesthesia. It was described that approximately 2 days post vaccination with the third dose of the vaccine, the patient developed headache then 2 days later developed spinal sensory syndrome and paraesthesia. The patient was referred to a neurologist who identified particularly aggressive multiple lesions. On 20-JUN-2008, the patient''s outcome was unknown. The agency considered that headache, central nervous system lesion and paraesthesia were possibly related to therapy with GARDASIL. The original reporting source was not provided. The agency considered the events to be serious for the following reason: medically significant. Additional information is not expected.

VAERS ID:321250 (history)  Vaccinated:1995-05-09
Age:16.0  Onset:1998-04-01, Days after vaccination: 1058
Gender:Male  Submitted:2008-08-01, Days after onset: 3774
Location:Foreign  Entered:2008-08-04, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject had no relevant past medical history. The subject''s father presented with rheumatoid polyarthritis. He had a cousin (on maternal side) who was maybe suffering from multiple sclerosis.
Diagnostic Lab Data: Cerebrospinal fluid oligoclona, May1998, present; Lumbar puncture, May1998, see lab text; Neurological examination, May1998, normal; Nuclear magnetic resonance ima, May1998, see lab text; Nuclear magnetic resonance ima, Apr2002, see lab tex
CDC Split Type: B0508933A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Brain scan abnormal, CSF oligoclonal band present, CSF test abnormal, Chromatopsia, Extensor plantar response, Loss of control of legs, Lumbar puncture abnormal, Multiple sclerosis, Neurological examination normal, Nuclear magnetic resonance imaging abnormal, Ophthalmological examination abnormal, Optic neuritis, Paraesthesia, Scotoma, Sensory disturbance, Vertigo, Vision blurred, Visual acuity reduced
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (narrow), Ocular infections (broad)
Write-up: This case was reported by GSK Legal Department and described the occurrence of multiple sclerosis in an adult male subject (age was unspecified) who was vaccination with Hepatitis B vaccine, manufacturer unspecified. This case was legally significant. In 1995 and 1997, the subject received two series of vaccination with an unspecified hepatitis B vaccine (unknown batch reference). At an unspecified date after vaccination, he experienced multiple sclerosis. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. According to a neurological expert, the event was dubiously related to hepatitis B vaccine. This case has been linked with case B0508936A because it was reported by the same reporter. Follow-up received on 24 July 2008 by GSK Legal Department: The subject was 19 year-old at the time of first events. He had no relevant past medical history. The subject''s father presented with rheumatoid polyarthritis. A cousin (not first degree) of his mother suffered from multiple sclerosis. On 01 April and 09 May 1995, the subject received the two first doses of ENGERIX B, GlaxoSmithKline) (batch number not available). On 29 October and 01 December 1997, he received two other doses of GENHEVAC B, Sanofi Pasteur MSD). No other doses of hepatitis B vaccine was administered. At the end of April 1998, three years after vaccination with ENGERIX B and four months after vaccination with GENHEVAC B, the subject presented with decreased visual activity of right eye. Ophthalmologist examination evidenced an inflammatory neuro-papillitis with dyschromatopsia and para-central scotoma. Those ophthalmologic events led to the subject''s hospitalisation in neurological unit from 04 to 07 May 1998. Neurological examination was normal (except visual disorder). Lumbar puncture revealed an oligoclonal aspect of immunoglobulins with intra-thecal IgG synthesis. Blood meningeal barrier was not altered. Brain scan showed left frontal round contrast-enhancing image. Cerebral MRI showe

VAERS ID:321287 (history)  Vaccinated:2007-09-06
Age:16.0  Onset:2007-09-12, Days after vaccination: 6
Gender:Female  Submitted:2008-08-04, Days after onset: 327
Location:Foreign  Entered:2008-08-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807AUS00274
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0138U2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Diplopia, Hypoaesthesia facial, Monoparesis, Myelitis transverse, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (broad)
Write-up: Information was obtained on request by the Company from the agency concerning a 16 year old female who had received a total of 3 doses of GARDASIL (not all vaccination dates were reported). Her first 2 vaccinations included one given on 10-MAY-2007 (Lot No. 655742/0138U, Batch No. J0798, Expiry date 07-AUG-2009). On 06-SEP-2007, she was vaccinated with her third dose of GARDASIL (Lot No. 655742/0138U, Batch No. J0799, Expiry date 07-AUG-2009). On 12-SEP-2007 the patient experienced asthenia (described as left leg weakness), myelitis transverse (described as incomplete transverse myelitis), diplopia, hypoaesthesia facial (described as facial numbness), monoparesis, nausea and vomiting. At the time of reporting to the agency on 10-JUL-2007, the outcome of asthenia, myelitis transverse, diplopia, hypoaesthesia facial, monoparesis, nausea and vomiting was unknown. The agency considered that asthenia, myelitis transverse, diplopia, hypoaesthesia facial, monoparesis, nausea and vomiting were possibly related to therapy with GARDASIL. The original reporting source was not provided. The agency considered the events of asthenia, myelitis transverse, diplopia, hypoaesthesia facial, monoparesis, nausea and vomiting to be serious for the following reason: medically significant. Additional information is not expected.

VAERS ID:321291 (history)  Vaccinated:2007-11-08
Age:16.0  Onset:2008-04-12, Days after vaccination: 156
Gender:Female  Submitted:2008-08-04, Days after onset: 114
Location:Foreign  Entered:2008-08-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Dizziness postural
Diagnostic Lab Data: ophthalmological, 17Apr08, Comment: definite good fixation and lang stereo test was completely positive; magnetic resonance imaging, 18Apr08, Comment: normal results; head and bone marrow; spinal tap, 18Apr08, Comment: normal results; elect
CDC Split Type: WAES0807USA05441
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Back pain, Blindness, Bone pain, Dizziness, Electroencephalogram normal, Fall, Headache, Lumbar puncture normal, Neurological examination normal, Nuclear magnetic resonance imaging brain normal, Ophthalmological examination normal, Optic neuritis, Physiotherapy, Vision blurred, Visual evoked potentials normal
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Accidents and injuries (narrow), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Osteonecrosis (broad), Ocular infections (broad)
Write-up: Information has been received from a gynecologist concerning a 16 year old female with a history of dizziness postural (2006), who on 05-SEP-2007 was vaccinated with the first dose of GARDASIL intramuscular (lot no. not reported) and on the same day was vaccinated with hepatitis B virus vaccine rHBsAg intramuscular. The second dose of GARDSASIL (lot no. not reported) was administered on 08-NOv-2007 and the third dose of GARDASIL (lot no. not reported) on 08-MAY-2008. Since 12-APR-2008 the patient complained of increasing blurred vision of the right eye. A few days later, on 17-APR-2008, she complained of complete loss of vision on her right eye, accompanied by intense headache. Outpatient neurological and ophthalmic exams showed no pathologies (no exact results reported), but high dose prednisone therapy (manufacturer unknown) 1000 mg, intravenous daily, was initiated (suspected diagnosis "optic neuritis"). Because of the side effects, nausea and dizziness, the mother refused this therapy after 3 days. The patient was hospitalized from 22-APR-2008 to 25-APR-2008. Cranial magnetic resonance imaging and cerebrospinal fluid showed normal results, as well as an electroencephalography performed on 24-APR-2008 and visual evoked potential performed on 25-APR-2008. On 05-MAY-2008, the patient fell on her back and had pain of the cervical spine with headache and dizziness. She went to see an orthopedist and also complained of pain in the lumbar spine since the lumbar punction performed on 22-APR-2008. The patient was treated with physiotherapy. On 17-JUL-2008, the patient again had an ophthalmologic check up, this time in a ophthalmologic department of a hospital. Fixation was good with both eyes and also Lang stereo test was completely positive (proof for intact stereoscopic vision). According to the ophthalmologist, "aggravation'' of the symptoms must be considered; he evoked the diagnosis of "schoolgirl syndrome" and suggested psychotherapy. Other business partner numbers included: E2008-07071. Additional information ha

VAERS ID:321506 (history)  Vaccinated:2007-05-02
Age:16.0  Onset:2007-10-10, Days after vaccination: 161
Gender:Female  Submitted:2008-08-06, Days after onset: 301
Location:Foreign  Entered:2008-08-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807AUS00280
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0138U0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Athetosis, Central nervous system inflammation, Dizziness, Headache, Loss of control of legs, Memory impairment, Muscular weakness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information was obtained on request by the Company from the agency via a Public Case Detail Form concerning a 16 year old female who on 02-MAY-2007 was vaccinated with the first dose of GARDASIL (Batch # J0798, Expiry date 07-AUG-2008, Lot # 655742/0138U). After vaccination with the first dose of GARDASIL, the patient experienced dizziness. On 13-JUN-2007 the patient was vaccinated with the second dose of GARDASIL (Batch # J0800, Expiry date 07-AUG-2009, Lot # 655742/0138U). After the second dose of GARDASIL, the patient developed headaches and was concerned about memory impairment. On 19-SEP-2007 the patient was vaccinated with the third dose of GARDASIL (Batch # J2300, Expiry date 12-FEB-2010, Lot # 657872/0583U). On 23-SEP-2007, a few days after the third dose of GARDASIL the patient got up during the night and lost control of her legs and collapsed. The next morning she had recovered. On approximately 10-OCT-2007, approximately 3 weeks after the third dose of GARDASIL, the patient developed right hand weakness and was referred to a neurologist. The patient was treated with methylprednisone to assist in recovery. On 30-JAN-2008 the patient was diagnosed with multifocal central nervous system (CNS) inflammatory disorder, presented with pseudoathetosis. It was advised that the patient recovered over 3 months. At the time of reporting to the agency on 10-JUL-2008 the patient had recovered from the athetosis, asthenia and central nervous system inflammation. The agency considered that athetosis, asthenia and central nervous system inflammation were possibly related to therapy with GARDASIL. The original reporting source was not provided. The agency considered the events of athetosis, asthenia and central nervous system inflammation to be serious for the following reason: medically significant. Additional information is not expected.

VAERS ID:322392 (history)  Vaccinated:2006-11-29
Age:16.0  Onset:2006-12-11, Days after vaccination: 12
Gender:Male  Submitted:2008-08-15, Days after onset: 612
Location:Foreign  Entered:2008-08-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Obesity
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 13Dec2006, up to 39deg. C; CSF cell count, 15Dec2006, 257/mcL; CSF cell count, 05Jan2007, 28/mcL; Cerebrospinal fluid lymphocyte, 15Dec2006, 80%; Cerebrospinal fluid lymphocyte, 15Dec2006, 80%; Cerebrospinal fluid lymphocy
CDC Split Type: B0532722A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERCHBND44970 IMUN
TD: TD ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALSAC128014CE IMUN
Administered by: Other     Purchased by: Other
Symptoms: Apathy, Ataxia, Body temperature increased, Brain stem syndrome, CSF cell count abnormal, CSF lymphocyte count increased, Catheter placement, Central nervous system lesion, Depression, Dizziness, Encephalitis, Gait disturbance, Leukoencephalomyelitis, Lumbar puncture abnormal, Meningism, Muscular weakness, Myalgia, Nuclear magnetic resonance imaging abnormal, Ophthalmological examination abnormal, Papillitis, Pleocytosis, Polymerase chain reaction, Pyrexia, Stress, Urinary incontinence, Urinary retention, Visual disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Malignant lymphomas (broad)
Write-up: This case was reported by a regulatory authority (# 2008-3037) and described the occurrence of encephalomyelitis in a 16-year-old male subject who was vaccinated with DITANRIX (GlaxoSmithKline), (non-GSK) (HBVAXPRO). Concurrent medical conditions included obesity since 1996. On 29 November 2006, the subject received unspecified dose of DITANRIX (intramuscular, unknown injection site), unspecified dose of HBVAXPRO (intramuscular, unknown injection site). On 11 December 2006, 12 days after vaccination with DITANRIX and HBVAXPRO, the subject was hospitalized due to an acute urinary retention. So far the patient had an inconspicuous miction anamnesis. Sonography had not shown a concretion, likewise no space occupying process. The bladder was filled with 1.2 l urine and therefore a continuous catheter was inserted. After several attempts to reduce the volume a ZYSTOFIX insert had to be carried out on 15 December 2006. In the course of the hospitalisation the patient developed starting at the 13 December 2006 gait ataxia, staggering dizziness, leg weakness, fever (up to 39 deg. C), muscle (CRP was not increased). On 15 December 2006 additionally meningism, why the same day a lumbar puncture was carried out which showed a lymphocytic pleocytosis (total cell count 257/mcL, 16% monocytes/macrophages and 80% lymphocytes), Liquor bacteriology, PCR investigation (Listeria monocytogenes, Herpes simplex, Varicella zoster) as well as serology (HIV, hepatitis A-C, Borrelia, Herpes simplex, measles, mumps, Treponema, FSME) were negative, likewise a rheumatologic examination. A cranium CT was performed on 15 December 2006 and was inconspicuous. For the exclusion of a myelitic lesion, which would explain urinary retention, a long spine MRI was carried out on 16 December 2006, which was inconspicuous. During the hospitalisation the staggering dizziness with gait ataxia persisted, why on 29 December 2006 a MRI of the cranium was carried out. There signal alterations were found pontine as well as mesencephal left and high

VAERS ID:322551 (history)  Vaccinated:2008-01-18
Age:16.0  Onset:2008-01-21, Days after vaccination: 3
Gender:Female  Submitted:2008-08-18, Days after onset: 209
Location:Foreign  Entered:2008-08-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: electrocardiogram, normal; electroencephalography, normal; computed axial tomography, normal; magnetic resonance imaging, normal
CDC Split Type: WAES0808USA01976
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0510U0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Computerised tomogram normal, Electrocardiogram normal, Electroencephalogram normal, Muscular weakness, Nuclear magnetic resonance imaging normal, Paralysis, Presyncope, Vaccine positive rechallenge
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from general physician who is specialized in homeopathic medicine via health authorities (HA reference no. PEI2008009659) concerning a 16 year old female who on 18-JAN-2008 was vaccinated with the first dose of GARDASIL (Lot No. 0510U; Batch No: NG20180). On 21-JAN-2008, patient experienced ongoing muscle weakness and presyncopes. On 18-MAR-2008 the patient was vaccinated with the second dose of GARDASIL (Lot No. 1113U; Batch No. NH04240). One week p.v (approximately on 25-MAR-2008), the patient experienced with aggravated postvaccinal paralytic weakness attacks (no symptoms specified) and aggravated presyncopes. Electrocardiogram, electroencephalography, computed axial tomography and magnetic resonance imaging showed normal results. The patient was hospitalized twice on an unknown dates. At the time of report to health authority (on 30-JUL-2008) the patient had not yet recovered. Other business partner numbers included: E2008-07559. Additional information has been requested.

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