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This is VAERS ID 618800

Case Details

VAERS ID: 618800 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2015-09-24
Onset:2015-09-24
   Days after vaccination:0
Submitted: 2015-11-19
   Days after onset:56
Entered: 2015-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K006975 / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Fatigue, Inflammatory marker increased, Lethargy, Loss of personal independence in daily activities, Myalgia, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ibuprofen; Acetaminophen; Albuterol
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: White blood cell count (unknown date in 2015): Raised (increased). Inflammatory marker test (unknown date in 2015): Raised (increased).
CDC Split Type: WAES1511GBR009462

Write-up: Information has been received from Sanofi Pasteur MSD (Manufacturer control # E2015-13009) on 17-NOV-2015, as a part of business agreement. This serious case was reported from the RA on 13/Nov/2015. GB-MHRA-ADR 23218631. This case is medically confirmed as it was reported from a HCP. A 12 year-old female patient, with no medical history reported, received an injection of GARDASIL, lot K006975, via IM route, dose 1, site not reported, on 24/Sep/2015. Patient was concomitantly receiving ibuprofen, paracetamol and salbutamol (doses and indications not reported). Approximately 1 hour following first vaccination, on 24/Sep/2015, patient developed muscle aching in her back legs which is ongoing. Patient is suffering from severe fatigue and lethargy which is also ongoing. The pain in her back has been so severe at times that she has had to be collected from school and taken home and she is unable to do physical activities such as physical education. Patient''s mother reports that her GP has taken blood samples. The blood tests are being repeated next week to rule out a viral infection and if they are still raised she is being referred to a pediatrician. No onset date was reported for pain back. At the time of reporting the outcome for the AEs was reported as not recovered. The RA considers this case serious, due to patient disability.


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