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This is VAERS ID 634213

Case Details

VAERS ID: 634213 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
   Days after vaccination:1
Submitted: 2016-05-03
   Days after onset:1511
Entered: 2016-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Chest pain, Dyspnoea, Fatigue, Head injury, Headache, Injection site swelling, Palpitations, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1604IRL017976

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # IE-1577272925-2016004775) as part of business agreement on 28-APR-2016. This case was received from RA in Ireland (Ref no. IE-HPRA-2016-026477) on 27-APR-2016. Initial case received from a consumer/other non health professional concerns a 14-year-old female adolescent patient received GARDASIL (batch number NN40800) on 14-SEP-2011, GARDASIL (batch number NP26080) on an unknown date, GARDASIL (batch number GO14502) on 13-MAR-2012. Concomitant medications: None. Medical history/concurrent conditions: Not reported. The patient experienced headaches, swelling of injection site, difficulty breathing, severe chest pain, postural tachycardia syndrome, palpitations, seizures - with many bangs on the head on 14-MAR-2012, constantly fainting and chronic fatigue on an unknown date. The reporter assessed the causal relationship between Headache, Swelling of injection site, Difficulty breathing, Chest pain, Postural orthostatic tachycardia, Palpitations, Seizures, Fainting, Chronic fatigue and GARDASIL as Unknown. Corrective treatment: The patient has attended GPs and hospitals and has commenced sodium, SSRI medication and an additional medication (to be confirmed). The patient''s outcome was reported as Not Recovered/Not Resolved.

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