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This is VAERS ID 674460

Case Details

VAERS ID: 674460 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-11-12
Onset:2014-08-10
   Days after vaccination:636
Submitted: 2016-10-10
   Days after onset:792
Entered: 2016-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H008259 / 2 UN / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Anxiety, Cystitis, Depression, Dizziness, Fatigue, Feeling abnormal, Gastric disorder, Headache, Insomnia, Menstrual disorder, Motion sickness, Muscular weakness, Nausea, Oropharyngeal pain, Ovarian cyst ruptured, Rash, Skin striae, Syncope, Tonsillitis
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1610IRL003237

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) MFR# IE-1577272925-2016010019) on 07-OCT-2016. This report was received from RA on 04-OCT-2016 under reference number IE-HPRA-2016-027923. Initial Case received from a consumer/non health professional which concerns a 12-year-old female adolescent patient received the first dose of GARDASIL (batch number G019345) via intravenous route on 17-Sep-2012 and the second dose of GARDASIL (batch number H008259) on 12-Nov-2012 and BOOSTRIX on 12-Nov-2012. The patient experienced chronic fatigue, muscle weakness, chronic gastric disturbance, fainting, dizziness, brain fog, headaches, recurring sore throat, tonsillitis, anxiety, depression, insomnia, cystitis, rash, stretch marks, ruptured ovarian cyst and ongoing menstruated issues on 10-Aug-2014, 636 days Post Administration; nausea and motion sickness on an unknown date. Corrective treatment: The patient has ongoing visits to GPs, hospitals and specialists. The reporter indicated that the patient has missed long periods of school and her symptoms are disabling her. The patient''s outcome was reported as Not Recovered/Not Resolved. The reporter assessed the causal relationship: -between Chronic fatigue and GARDASIL as Unknown -between Muscle weakness and GARDASIL as Unknown -between Gastric disorder and GARDASIL as Unknown -between Fainting and GARDASIL as Unknown -between Dizziness and GARDASIL as Unknown -between Foggy feeling in head and GARDASIL as Unknown -Headache and GARDASIL as Unknown -between Sore throat and GARDASIL as Unknown -between Tonsillitis and GARDASIL as Unknown -between Anxiety and GARDASIL as Unknown -between Depression and GARDASIL as Unknown -between Insomnia and GARDASIL as Unknown -between Cystitis and GARDASIL as Unknown -between Rash and GARDASIL as Unknown -between Stretch marks and GARDASIL as Unknown -between Ovarian cyst ruptured and GARDASIL as Unknown -between Menstrual cycle abnormal and GARDASIL as Unknown -between Nausea and GARDASIL as Unknown -between Motion sickness and GARDASIL as Unknown. Upon our internal review, BOOSTRIX was added as a suspect vaccine as it was given on the same day with the second dose of GARDASIL vaccine.


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