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Life Threatening? No
Write-up: Case received from a consumer or other non health care professional via the Health Authorities in a foreign country on 04-Jul-2013 under the references DK-DKMA-ADR 22156768 and DK-DKMA EFO6162. Case not medically confirmed. A 12-year-old female patient, had received the second injection of GARDASIL (batch number not reported) via not reported route and site of administration on an unspecified date. On 08-Mar-2012, the patient developed chronic nausea, chronic headache and severe tiredness. The patient was hospitalised. The patient received D3 of GARDASIL on 24-Sep-2012. At the time of reporting, the patient had not recovered. The patient received D1 of GARDASIL on 02-Jan-2012, toleration not reported. Follow up report received from the Health Authorities in a foreign country on 01-Aug-2013: The Health Authorities tried to obtain medical confirmation of the report. The patient''s physician provided the patient''s initials and the administration date (08-Mar-2012) of the second dose of GARDASIL. The physician could not confirm whether the patient had developed the reported events and could not provide an causality assessment. The report therefore remained as not medically confirmed. Follow-up information was received from health care professionals via the Health Authorities in a foreign country on 21-Oct-2013 and 22-Oct-2013. The reference number DK-DKMA-EFO7182 and DK-DKMA-ADR 22275018 were added (case reported by physician, information has been merged by HA). The case is now medically confirmed. The patient''s initials were updated. The patient has a history of dermatitis atopic and hay fever, which are both continuing. The patient received the first dose of GARDASIL (batch number NN30600, lot # NM02340, exp date 31-DEC-2012 i.m.) on 02-Jan-2012 (previously reported in history). As the patient experienced the first adverse events after this first dose, it is now considered as suspect product. The second dose of GARDASIL (given on 08-Mar-2012) had batch number NP26930, Lot # NK47540, exp date 31-MAY-2012 and the third dose (given on 24-Sep-2012) had batch number H01175; both given i.m. PRIORIX (other mfr) was administered on 02-Jan-2012 and was reported as concomitant medication. It was reported that the patient fainted three times after HPV vaccination and she experienced dizziness, muscle pain and aggravation of hay fever and child eczema, with onset 07-Jan-2012. She experienced malaise and concentration impaired, with onset 15-Jan-2012. She developed black outs with onset 08-Mar-2012. The onset of tiredness was changed to 15-Jan-2012 (previously reported: 08-Mar-2012). After the HPV vaccination the patient has been tired and fainted three times. The patient was tired and could not attend school. Her hay fever and child eczema was aggravated. She experienced headache, dizziness and muscle pain. According to the physician the above mentioned adverse events caused invalidity or severe function impairment. The girls also experienced two blackouts after the second vaccination with GARDASIL. With the increased development of tiredness, indisposition and malaise as well as headache and concentration impairment, the girl was not able to follow school, despite good intelligence. The patient has been examined and have had blood tests or similar. She is currently under investigation at a hospital. Lab data received to HA from the doctor 27-Sep-2013: No abnormality apart from allergy tests: IgE 0.55, grass allergy test 0.45. Reporting from hospital doctor: MRI of the cerebrum nothing abnormal. Polysomnography performed 26-Jun-2013 showed a total sleep time with 3 sleeping periods, these is localized early afternoon, early evening and late night, with the patient in the last period fell asleep around 03 in the morning. Each of the sleep periods are with normal NREM/REM subtlety. There were no motor or respiratory episodes and ECG showed sinus rhythm, no paroxystic activity during any of these. Subsequently MSLT (Multiple Sleep Latency test) showed normal sleep latency, and there was a single episode of REM sleep in test 3, all in all normal MSLT. Thyroid numbers, red and white blood cell normal, IGE elevation checked by prick test, which was negative. Examination for intestinal parasites negative. Examined by a psychiatrist who has not found evidence of psychiatric disorder. EBV negative. The outcome was reported as not recovered, except for concentration impaired and blackouts where outcome was unknown.
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