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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number DK-1577272925-E2015-03635) on 15-MAR-2016. Case received from health care professional via Heath Authorities on 15-APR-2015 under the reference number DK-DKMA-ADR 22953355 and DK-DKMA-EFO11695. The primary reporter was a physician. A 12 year old female patient (weight: 60kg, height: 168cm) with no information on medical history, had received three doses of GARDASIL (batch number not reported) via intramuscular route of administration in unspecified site of administration on 27-MAR-2012 and dose and three on unspecified dates and later on 15-OCT-2012, she developed tendency to faint/fainting occasion. She had no other or medications. Blood tests, EKG and CardioCall showed nothing abnormal. Noteworthy: The HA reported batch number H016967 and H014677 but did not specify which dose each batch number corresponds to. The HA assessed this case as serious due to disability. At the time of reporting, the patient was recovering. Follow up information received on 07-OCT-2015 from HA. The HA received Follow up information from the patient''s general practitioner after a request from Sanofi Pasteur MSD: The patient was vaccinated at the following dates with corresponding batch number: On 27-MAR-2012 (batch number not noted in the medical records and cannot be informed), on 26-NOV-2012 (H016967) and on 02-APR-2013 (H014667). The case has been updated with the following based on the follow-up: Lot not rep changed to Lot UNK for D1, Date of vaccination (26-NOV-2012) and batch number H016967 (corrected on 14-OCT-2015) added for D2, Date of vaccination (02-APR-2013) and batch number H014667 added for D3. A corrective version was created on 14-OCT-2015 to correct a discrepancy between the narrative and structural fields regarding batch number for D2. The batch number for D2 was incorrectly mentioned in the narrative as H014667, this has now been corrected to the correct batch number H016967. Lot number H014667 has been verified to be an invalid lot number for GARDASIL. Follow up information received on 11-MAR-2015 from the HA. The HA received the follow up information from the Patient Insurance Company (PIC) on 09-MAR-2016 with case number 16-0731. This is the patient''s initial case, the PIC has not yet made a decision. The patient describes that a few weeks after HPV vaccine she developed severe headache (almost daily). After approximately 6 months fainting. Symptoms: Constant tired, neck tension, headaches, cold hands, dizzy, muscle and joint pain, fainting, nausea, chest pain, cannot do sports, no energy. The patient is treated with GUTRON 3 daily. The patient was before the vaccination a very active girl. Cultivated much sport. Went on gymnastics boarding school, from being a very active girl, now she cannot do anything. There were many sick days from school due to symptoms. The energy was completely gone. She was lay some periods 5-10 days without being able anything. Added adverse events by the HA: Tiredness, Neck tightness, headache, cold hands, Dizziness, muscle pain, joint pain, nausea, chest pain, exercise capacity decreased, feeling of total lack of energy. All with outcome not recovered and onset were date not reported. MA comments: Follow-up received on 07-OCT-2015 it was described in the narrative that the first vaccine was given on 27-MAR-2015, this was wrong, it should be 27-MAR-2012.
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