Kleine-Levin syndrome (KLS) is the commonest recurrent sleep disorder, with a prevalence of 1-2 per million population. Clear diagnostic criteria are now defined, but effective treatment remains elusive. The significant body of published literature allows consideration of possible aetiological mechanisms, an understanding of which could guide the development of therapeutic strategies. Functional imaging studies have been inconclusive; although diencephalic abnormalities are a common finding, no consistent pattern has emerged, and these studies have not revealed the mechanism(s) underlying the development of the abnormalities detected. An autoimmune aetiology is consistent with the available data. In this review, we argue that, in order to further our understanding of KLS, there needs to be a co-ordinated international effort to standardise approaches to functional imaging studies, genetic analyses that specifically address the possibility of an autoimmune aetiology, and clinical trials of immunosuppressive therapies.
デンマークの報告例では、3回目のガーダシル接種の4日後に発症
Vaccinated: |
2012-06-27 |
Onset: |
0000-00-00 |
Submitted: |
2013-12-05 |
Entered: |
2013-12-05 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
NK47540 / 3 |
UN / IM |
Administered by: Other Purchased by: Other
Symptoms: Decreased activity, Decreased appetite, Derealisation, Electroencephalogram normal, Fatigue, Hypersomnia, Liver function test normal, Nuclear magnetic resonance imaging brain normal, Red blood cell scan, Renal function test normal, Somnolence, Thyroid function test normal, White blood cell count normal
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? 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: 01/11/2012, GARDASIL, Immunisation; 03/05/2012, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: Blood pressure was normal. Thyroid function test normal. Erythrocyte scan normal. WBC normal. Renal function test normal. Liver function test normal. 24-MAY-2013: MRI cerebrum was normal. 11-MAR-2013: EEG normal.
CDC Split Type: WAES1312DNK001670
Write-up: Case received from a healthcare professional via the Health Authorities on 28-Nov-2013 under the references DK-DKMA-ADR 22275019 and DK-DKMA-EFO7183 from Sanofi Pasteur MSD (reference # DK-1577272925-E2013-10114) on 03-DEC-2013. Case is medically confirmed. The primary reporter was a physician. A 12-year-old female patient (weight 46 kg, height 158 cm) with no medical history had received the third injection of GARDASIL, (batch number NP26930, lot number NK47540, expiration date 31-MAY-2012) via intramuscularly into not reported site of administration of 27-Jun-2012. No other vaccines were given. On 01-Jul-2012, 4 days after vaccination, the patient developed hypersomnia. It began with 6 weeks of hypersomnia state and decreased psychomotor tempo, feeling of absence, disappeared again (no more information was provided). In addition, the patient had episodes in Aug-2012, Dec-2012, Jan-2013. She also developed episodes from 09-Mar-2013 to 15-Mar-2013 and from 03-Apr-2013 to 07-Apr-2013. The symptoms were the same every time with severe tiredness, feeling of absence and derealisation. The patient suffered from decreased appetite and wanted to sleep all the time. Patient was hospitalised on an unspecified date. On 24-May-2013, MRI was performed and cerebrum was normal. On 11-Mar-2013, EEG was normal. Blood pressure, thyroid count, red and white blood cells as well as kidney and liver function were normal. At the time of reporting, the patient was recovering from hypersomnia. The outcome of possible Kleine-Levin syndrome, appetite impaired, derealisation was unknown. According to the reporter, suspicion of possible side effect related to HPV-vaccination, possible Kleine-Levin syndrome. The patient had received GARDASIL via intramuscularly into not reported site of administration on 11-Jan-2012 (D1, batch number G004959, lot number NN12510, expiration date 19-SEP-2013) and on 05-Mar-2012 (D2, batch number G009615, lot number NN43360, expiration date 01-DEC-2013). Toleration was not reported.
VAERS ID: |
515752 (history) |
Form: |
Version 1.0 |
Age: |
12.0 |
Gender: |
Female |
Location: |
Foreign |
フランスの報告例では、3回目のガーダシル接種の3日後に発症
Vaccinated: |
2013-10-11 |
Onset: |
2013-10-14 |
Days after vaccination: |
3 |
Submitted: |
2014-03-11 |
Days after onset: |
148 |
Entered: |
2014-03-11 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Abnormal behaviour, Anxiety, Confusional state, Delirium, Disorientation, Hallucination, Hypersomnia, Hypersomnia-bulimia syndrome, Nuclear magnetic resonance imaging brain normal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (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, 2 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Nuclear magnetic resonance imaging brain, unremarkable N/A
CDC Split Type: WAES1403FRA004779
Write-up: Information has been received from SPMSD (manufacturer control #: FR-1577272925-E2014-01963) on 07-MAR-2014. Case received from the Health Authorities in a foreign country on 04-Mar-2014 under the reference number PP20140087. A 15-year-old female patient had received an injection of GARDASIL (batch number not reported) (dose and route unknown) on 11-Oct-2013 and 3 days later on 14-Oct-2013, she presented with a hypersomnia episode lasting for 10 days including behaviour disorders (apathy, loss of interest, speech impairment) and suicidal ideation requiring immediate admission of the patient at an emergency unit. On 25-Nov-2013, she experienced another hypersomnia episode which also lasted 10 days accompanied by confusion, spacial and temporal disorientation, delirious episodes, behaviour disorders and anxiety. According to the reporter, a diagnosis of suspected Kleine-Levin syndrome was suggested. On 23-Dec-2013, the patient presented with a third hypersomnia episode including hallucinations and bahaviour disorders. The MRI brain scan performed (date not reported) was unremarkable. On 09-Feb-2014, she was admitted at hospital in a sleep laboratory in order to confirm her diagnosis and was discharged on 1--Feb-2014. At the time of the report, the patient had still not recovered. The health Authorities assessed the causal relationship between the reported reactions and GARDASIL vaccination as doubtful (C1 S1 I1) according to the foreign method of assessment.
AERS ID: |
525553 (history) |
Form: |
Version 1.0 |
Age: |
15.0 |
Gender: |
Female |
Location: |
Foreign |