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Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (Sender''s case report number IE-1577272925-E2011-03985) on 24-SEP-2014. This case was reported by the agency on 27/Jun/2011, reference 2011-004459. This case is medically confirmed. A 14 year old female patient who received dose 1 of GARDASIL on an unreported date received dose 2 of GARDASIL batch NM46680 lot # NK44350 on 30/Nov/2010. An unknown time post vaccination the patient experienced tiredness, headaches and nausea. No corrective treatment was administered. The patient''s symptoms were continuing at the time of reporting to the agency. The agency considered the case to be serious as an other medically important condition requiring intervention. The patient was involved in a collision 1 week prior to the second dose and was not fully well at the time of vaccination with dose 2. The patient was not taking any concomitant medications. Follow up received from the regulatory authority on 19-Sep-2014: The reference number has been amended to 2011-003167. The patient had no history of reactions to previous vaccinations. The patient had a history of stomach pains on and off as a child. The patient had a history of a bang on the head for which she did not receive any treatment. A couple of days post vaccination (approximately 01-02/Dec/2010) the patient experienced fatigue, intermittent headaches and nausea which led to vomiting. The symptoms worsened by the weekend. The patient visited the doctor in December 2010 and January 2011 and the doctor suspected a virus. The patient was then referred to a paediatrician who did not have any findings but suggested the patient visited a psychologist. The mother then suggested to the paediatrician that the patient may have an ulcer. The paediatrician treated the patient with unspecified antibiotics. The patient also visited a kinesiologist who provided the patient with some type of detox and booster drops which seemed to be helping. The patient underwent a number of blood tests including a test for glandular fever which all came back clear. The patient''s mother reported that the patient''s symptoms were persisting and the patient had been out of school since the vaccination and had only attended to sit exams. The patient described feeling completely exhausted as if there was a blanket of tiredness over her. The patient''s sleep patterns also went awry however they are starting to come back to normality. The patient''s mother was now sending her to school for a few hours every day. The patient was not taking any concomitant medication and the patient''s mother felt she had a cold prior to vaccination. At the time of reporting the patient continued to experience nausea, headaches and fatigue since the vaccination in 2010 and has been diagnosed with chronic fatigue. The regulatory authority amended the event terms to fatigue/exhausted, nausea, intermittent headaches, vomiting, sleep patterns awry and chronic fatigue with outcomes of not recovered. The seriousness criterion was amended to disability.
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