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This is VAERS ID 619332

Case Details

VAERS ID: 619332 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-04-16
Onset:0000-00-00
Submitted: 2015-12-07
Entered: 2015-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Asthma, Back pain, Blood count normal, Chest discomfort, Dizziness, Dry skin, Fatigue, Gingivitis, Headache, Hyperhidrosis, Laboratory test abnormal, Lactose intolerance, Nasal congestion, Nausea, Pallor, Rhinorrhoea, Sneezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal infections (narrow), Gingival disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: HPV immunisation
Preexisting Conditions: Asthma
Diagnostic Lab Data: Normal blood count and positive for lactose intolerance
CDC Split Type: WAES1512DNK002902

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # DK-1577272925-2015000147) on 04-DEC-2015. The report type of the case is unsolicited spontaneous. Case received from a consumer/other non health prof and health care professional on 30-NOV-2015. Reference number DK-DKMA-WBS-0001625, DK-DKMA-ADR 23225264, DK-DKMA-WBS-0001863, DK-DKMA-WBS-0001625, DK-DKMA-WBS-0001863. It refers to a 13-year-old female patient (weight 57 kg; length 162 cm). The health authority has received two reports, one from the patient on 08-NOV-2015 (ADR 23225264) and one from her own physician on 27-NOV-2015 (ADR 23253003), which are merged before sent out to Agency. ADR 23222564 is the master case, and can consider the second version as the initial report. The patient received three doses of GARDASIL, (batch numbers not reported): Dose 1 on 08-OCT-2008, dose 2 on 15-DEC-2008 and dose 3 on 16-APR-2009. Reported by the patient: adverse events Varying fatigue (normal-severe) (onset date 2008, outcome not recovered), Nose congestion (onset 2009, outcome not recovered), Abdominal distension (onset 2009, outcome not recovered), Developed lactose intolerance (diagnosed in 2013, onset date 2009, outcome not recovered), Increased sweat production (onset 2009, outcome not recovered), Abdominal pain (onset 2009, outcome not recovered), Dizziness (onset 2009, outcome not recovered), Developed asthma (diagnosed in 2012, onset date 2009, outcome not recovered), Sneezing (onset 2009, outcome not recovered), Runny nose (onset 2009, outcome not recovered), Pain in the back/lumbar (onset 2009, outcome not recovered), Gingivitis (onset 2015, outcome recovering), Dry skin (onset 2009, outcome not recovered), Nausea (onset 2009, outcome not recovered), Pale (onset 2009. outcome not recovered), Periodic chest tightness (onset 2012, outcome not recovered), Headache (onset 2008, outcome not recovered), Dry hair (onset 2009, outcome not recovered). The patient has not been treated or hospitalized for the adverse reactions. No other medicines. Notes: the patient has been healthy and very seldom sick during childhood and youth, the negative development started after HPV-vaccination. Reported from the physician: adverse events tiredness and lactose intolerance. The case is medically confirmed. Medical history: Asthma.


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