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This is VAERS ID 500212

Case Details

VAERS ID: 500212 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-06-12
Onset:2013-06-26
   Days after vaccination:14
Submitted: 2013-08-22
   Days after onset:57
Entered: 2013-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H016574 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Computerised tomogram head abnormal, Confusional state, Depressed mood, Disturbance in attention, Dizziness, Impaired work ability, Libido decreased, Mental status changes, Musculoskeletal disorder, Myalgia, Nausea, Speech disorder, Stress, Transient ischaemic attack
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: CT (cerebral) was performed on an unspecified date with nothing abnormal as result.
CDC Split Type: WAES1308DNK009746

Write-up: Case received from a health care professional via the Health Authorities in a foreign country on 15-Aug-2013 under the reference number DK-DKMA-ADR 22208286 and DK-DKMA-EFO6541. Case medically confirmed. A 42 year old female patient (height 174 cm, weight 85 kilogram) had received an injection of GARDASIL (dose 2, batch number H016574, intramuscular route, site of administration not reported) on 12-Jun-2013 and later on 26-Jun-2013 (i.e. 14 days p-v) she developed Transient Cerebral Ischaemia (TCI), difficulty speaking and difficulty controlling right arm and leg. The patient was hospitalized due to the events. CT (cerebral) was performed on an unspecified date with nothing abnormal as a result. The patient''s medical history includes: First GARDASIL vaccination (dose 1, batch number not reported, site and route of administration not reported) on 06-Mar-2013. Previously healthy patient. At the time of reporting, the outcome was unknown. Additional information received from health authority on 19-Aug-2013. Additional reference number received: DK-DKMA-ADR 22213488 and DK-DKMA-EFO6584. HA received information from the patient. Patient initials, height: 165 cm, weight 89 kilogram updated and changed. According to the patient, she developed speech impairment, confusion, dizziness, nausea, concentration impaired, TCI/blood clots, tiredness, tender muscles, mentally unstable, anxiety, sadness, quickly stress, decreased sex drive. Due to these symptoms the patient was absent from work for 5 weeks and had to start seeing a psychologist. She is very sad all the time. The patient received the following treatment for the side effect: clopidogrel (other MFR) and simvastatin (other MFR). HA added AE with outcome and onset as follows: quickly stress: unknown (onset not reported), sadness: unknown (onset not reported), anxiety: unknown (onset not reported), decreased sex drive: unknown (onset not reported), confusion: not recovered (onset 26-Jun-2013), concentration impaired: not recovered (onset 26-Jun-2013), tender muscles: unknown (onset not reported), mentally unstable: unknown (onset not reported), dizziness: not recovered (onset 26-Jun-2013), tiredness: unknown (onset not reported), nausea: not recovered (onset 26-Jun-2013).


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