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This is VAERS ID 336249

Case Details

VAERS ID: 336249 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-05-21
Onset:2007-05-28
   Days after vaccination:7
Submitted: 2008-12-26
   Days after onset:578
Entered: 2008-12-30
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1340F / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute disseminated encephalomyelitis, Chronic sinusitis, Computerised tomogram normal, Diagnostic procedure, Disability, Dizziness, Ear pain, Electroencephalogram normal, Febrile infection, Headache, Hypersensitivity, Hypothyroidism, Lymphadenopathy, Nuclear magnetic resonance imaging normal, Oropharyngeal pain, Pain, Sinusitis, Spondylolisthesis, Ultrasound scan normal
SMQs:, Angioedema (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (narrow), Demyelination (narrow), Hypothyroidism (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AUGMENTIN; OTRIVEN; thyroid
Current Illness:
Preexisting Conditions: Migraine; Lymph nodes enlarged; Hypersensitivity reaction
Allergies:
Diagnostic Lab Data: diagnostic laboratory test, 29Feb08, 10.4 IU/ml, mAK; orthostatic hypotension measurement, 13Mar08, Normal; electroencephalography, 14Mar08, Normal; magnetic resonance imaging, 26Mar08, Normal, spinal MRI; magnetic resonance imaging, 26Mar08, Normal, Cranial MRI; computed axial tomography, Normal; ultrasound, Normal; serum TSH, 10Jan08, 5.8 microIU/ml; serum antithyroid peroxidase antibody, 10Jan08, <30 KU/l; free serum triiodothyronine test, 10Jan08, 5.2 pmol/ml; free serum thyroxine index, 10Jan08, 17.0 pmol/l; serum TSH, 29Feb08, 3.75 microIU/ml; free serum triiodothyronine test, 29Feb08, 3.48 pg/ml; free serum thyroxine index, 29Feb08, 1.39 ng/dl; serum TSH, 09Apr08, 4.01 microIU/ml; free serum triiodothyronine test, 09Apr08, 3.24 pg/ml; free serum thyroxine index, 09Apr08, 1.44 ng/gl; urine ferric chloride test, 09Apr08, 26 microg/l
CDC Split Type: WAES0812USA04312

Write-up: Information has been received from Health Authority on 18-NOV-08. Health authority reported that 11 year old female patient was vaccinated with a second dose of GARDASIL (Lot # 1340F and batch NF14740) IM into the left arm on 21-MAY-07. On 28-MAY-07 the patient developed a "pain syndrome" concerning head and abdomen. CT, spinal MRI , examination of the eyes and teeth and "orthopedic examinations" showed normal results. The patient was hospitalized on an unspecified date. The situation was considered to be life-threatening. The reported assumed an acute disseminated encephalomyelitis. Despite ongoing events the patient was vaccinated with third dose of GARDASIL (Lot # 1536F batch NG01520) IM into the left arm on 04-OCT-07. The patient had not recovered at the time of reporting. The first dose of GARDASIL, lot # not reported administered on 23-FEB-07 was well tolerated. Follow up information received from Health Authority on 17-DEC-2008. Case is linked with E2008-10694 (WAES 0811USA03578) (different AEs and hospitalization after first dose). The patient has a history of migraine (without aura, but with vomiting, dizziness and nausea) since she was 7 years old and cramp-like abdominal pain in the course of menstrual bleeding (menarche at the age of 10). The patient was vaccinated with a second dose of GARDASIL (Lot # 1340F and batch NF14740) IM into the left arm on 21-MAY-2007. Five days after the second dose she developed a febrile infection with earache and sore throat. She was treated with antibiotics. Despite ongoing events she was vaccinated with D3 of GARDASIL (Lot # 1536F and batch NG01520) IM into the left arm on 04-OCT-07. Approximately 3 weeks after the third dose she developed intolerable headache and attacks of dizziness which led to disability. Hospital letter (13-MAY to 15-MAY-08): Latent hypothyroid metabolism was diagnosed, but sonography showed normal results. An autoimmune thyroid disorder was ruled out. The patient was treated with thyroid hormones. Schellong test on 13-MAR-2008 and EEG on 14-MAR-2008 showed normal results. Medication-induced headache was suspected because the patient was treated various analgetics due to several menstrual pain. Treatment with ASA almost daily for 8 weeks at this time. Examination by an ENT physician on 18-MAR-08 showed suspicion of chronic sinusitis which was treated with AUGMENTIN and OTRIVEN for 10 days. Paradoxical kyphosis of the cervical vertebral column because of retrospondylolisthesis at level cervical vertebra 5 was diagnosed (cervical MRI on 26-MAR-08). Additionally decent subluaxition of the dens to the left side was seen which might explain the cephalgia. Manual therapy improved symptoms temporally. Cranial MRI on 26-MAR-08 was normal. Laboratory test were performed. At the time of reporting 09-DEC-08 the patient had not recovered. The Health Authority concluded that not ADEM but subacute demyelinating encephalitis caused by the 3 vaccinations with GARDASIL is the final diagnosis. The first dose of GARDASIL lot # not reported was administered on 23-FEB-07. The patient developed enlarged lymph nodes behind the left ear and allergic reaction (not otherwise specified) after the first dose. Follow-up information on 17-DEC-2008: At the time of seven years diagnosis of migraine without aura was established. Severe pain (cramp-like) during menstruation for 2-3 years. The Health Authority considered encephalitis, sinusitis chronic, dizziness, earache, febrile infection, headache, latent hypothyroidism, sore throat, pain and retrospondylolisthesis were considered to be immediately life-threatening and disabling. Other business partner numbers include E2008-11850. File closed. No further information is available.


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