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This is VAERS ID 620635

Case Details

VAERS ID: 620635 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Submitted: 2016-01-12
Entered: 2016-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Alopecia, Arthralgia, Bowel movement irregularity, Cognitive disorder, Constipation, Depression, Disturbance in attention, Dizziness, Dyspnoea, Fatigue, Headache, Heart rate decreased, Heart rate increased, Hunger, Insomnia, Loss of personal independence in daily activities, Nausea, Orthostatic intolerance, Palpitations, Photophobia, Presyncope, Tilt table test positive, Tonsillar hypertrophy, Tremor, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (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), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Noninfectious diarrhoea (broad), Hypoglycaemia (broad), Dehydration (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: Human papilloma virus immunisation
Preexisting Conditions:
Diagnostic Lab Data: The patient has performed tilt table test at the Syncope center which showed orthostatic intolerance, but the patient does not fulfill the diagnostic criterion for POTS.
CDC Split Type: WAES1509DNK006839

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (DK-1577272925-E2015-10024) on 12-JAN-2016. Case received from non-healthcare professional via Health Authorities on 27-Jul-2015 under the reference numbers DK-DKMA-ADR 23071942 and DK-DKMA-WBS-0000443. The case is not medically confirmed. The primary reporter was a patient. A 13-year-old female patient (weight: 58 kg; height: 165 cm) had received the first dose of GARDASIL (batch number not reported) via I.M route of administration in unspecified site of administration on unspecified date in 2009. On unspecified date in 2011, she developed tiredness. On unspecified date in 2012, she developed headache and fluctuating hair loss. On unspecified date in 2013, she developed abdominal pain. On unspecified date in 2014, she experienced rapid heart pounding, slow heart pounding, increased hunger, vomiting, shaking hands while rapid heart pounding, sleeplessness, often swollen tonsils, constipation and changed bowel movement. On unspecified date in 2015, she developed concentration impaired, depressive and dizziness. The patient has not been treated for the adverse reactions. The patient has not been hospitalized due to the adverse reactions. No information on other vaccines and/or medications provided. No tests or procedures have been performed. The patient has otherwise no health issues. At the time of reporting, the patient was recovering from shaking hands while rapid heart pounding and dizziness. The patient had not recovered from the remaining reactions. Follow up information received on 5-Jan-2015 from the HA. The HA identified duplicate (DK-DKMA-ADR 23278860) from the Syncope center (physician), Hospital on 16Dec2015. Not previously sent to MAH, now merged with this master case. Adverse events reported: Headache, Fatigue, Near syncope, Dizziness, Orthostatic intolerance, Palpitation, Nausea, Abdominal pain, Dyspnea, Cognitive function abnormal, Pain knee, Hair loss, Light sensitivity to eye, Obstipation. After dose 3 of GARDASIL, headache and fatigue and other symptoms developed. In 2013, headaches and fatigue worsened considerably. The patient went to cheerleading and dance in Championship, but has stepped down over time. Going to high school, but has some absences due headache especially. The patient has performed tilt table test at the Syncope center which showed orthostatic intolerance, but the patient does not fulfill the diagnostic criterion for POTS. Other vaccines/medicines: unknown. Added/changed by the HA: case has been upgraded to serious due to seriousness criterion disability. Case is now medically confirmed. New adverse events added (please see above). Onset date for Headache and tiredness is changed to 2010. Outcome for Dizziness is changed to Not recovered. Vaccination dates added; dose 1 of GARDASIL 28Oct2009 and dose 2 22Dec2009. Patient initials are changed.

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