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Life Threatening? No
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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