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This is VAERS ID 522473

Case Details

VAERS ID: 522473 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-11-08
Onset:2013-11-16
   Days after vaccination:8
Submitted: 2014-02-12
   Days after onset:88
Entered: 2014-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J009200 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Audiogram abnormal, Borrelia test negative, C-reactive protein normal, Deafness neurosensory, Deafness unilateral, Epstein-Barr virus antibody positive, Neutrophil count decreased, Nuclear magnetic resonance imaging normal, Otoscopy normal, VIIth nerve paralysis, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 2012, Malaise, no neurological or heart etiology found after an exhaustive work-up
Allergies:
Diagnostic Lab Data: 12/27/2013, Audiogram, acoumetry/Weber: left-lateralised; 12/27/2013, Audiogram, right perceptive deafness, normal on the left; 11/20/2013, Borrelia test, Negative; 11/20/2013, C-reactive protein, 0.2; 11/27/2013, Ear, nose and throat examination, normal typanum, no anomalies on cranial nerves; 11/27/2013, Ear, nose and throat examination, normal bilateral otoscopy; 11/27/2013, Ear, nose and throat examination, parotid area palpation; 11/27/2013, Ear, nose and throat examination, house-brackman score for facial palsy=4; 12/04/2013, Ear, nose and throat examination, same facial palsy scoring; 12/27/2013, Ear, nose and throat exmaination, no hypoacousia, no; 12/27/2013, Ear, nose and throat examination, facial palsy scoring=4, improvement in lower area; 12/27/2013, Ear, nose and throat examination, impossible palpebral occlusion; 11/12/2013, Epstein-Barr virus test, IgG anti VCA, anti EBVNA, IgM antiVCA positive N/A; 11/20/2013, Epstein-Barr virus test, IgG anti VCA, anti EBVNA, IgM antiVCA positive; 11/20/2013, Neutrophil count, 1.35; 01/02/2014, Nuclear magnetic resonance imaging, normal pontocerebellar angle, no expansive process; 11/20/2013, White blood cell count, 4.48
CDC Split Type: WAES1402FRA004675

Write-up: Information has been received from SPMSD with MFR with E2014-00995, on 07-FEB-2014. Case received from the Health Authorities in a foreign country 04-Feb-2014 under the reference number LY20140105. A 12-year-old female patient had received first dose of GARDASIL (batch number J006656, expiry date: 31-OCT-2015) on 18-Sep-2013 and the second dose of GARDASIL (batch number J009200, expiry date: 31-OCT-2015) on 08-Nov-2013, both via intramuscular route. On 12-Nov-2013, Epstein-Barr virus serology was positive for IgG anti VCA, ant EBVNA and IgM antiVCA (not considered as a cause to the event). It was unknown why this serology was performed. A notion of excessive medication was reported. On 16-Nov-2013, the patient abruptly experienced right peripheral facial palsy. There was no notion of virosis in the previous days. On 20-Nov-2013, Epstein-Barr virus serology was positive again for IgG anti VCA, anti EBVNA and IgM antiVCA. Borrelia test was negative, C-reactive protein was at 0,2, White blood cell count at 4,48, Neutrophil count at 1,35. On 27-Nov-2013 ENT examination were performed, showing right isolated peripheral facial palsy of grade (House-Brackman). Parotidea area palpation was normal. Bilateral otoscopy was normal too. Tympanum were normal, and there was no anomaly on cranial nerves. According to the patient, the symptoms were regressing. On 04-Dec-2013, the patient underwent a further ENT examination, with the same facial palsy scoring. Speech therapy was initiated. On 27-Dec-2013, facial palsy scoring was still 4. An improvement in the lower area was observed. Palpebral occlusion was impossible. There was no hypoacousia and no dizziness. An audiogram was performed, which showed a very significant right perceptive deafness. The left side was unremarkable. Acoumetry showed left-lateralised Weber. On 02-Jan-2014, an MRI was performed. The results showed a normal pontocerebellar angle and no expansive process. At the time of reporting, the patient had not recovered. It is noteworthy that the patient had a medical history of recurring episodes malaises in 2012 with noneurological or heart etiology found after an exhaustive work-up. There was no recurrence since 2012. She had no medical history of allergy and there was no trip abroad. Vaccination schedule was up-to-date. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful (C1 S1 I1) according to the Foreign method of assessment.


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