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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Information has been received from a healthcare professional (local reference#: 2011MSDA1217) via CSL concerning a 13 year old female with no medical condition who on 11-FEB-2008, 05-MAY-2008, 04-AUG-2008 were vaccinated with the first, second and third dose of GARDASIL, respectively. There was no concomitant medication. The patient experienced regular menstrual cycles prior to the administration. In October 2008, the patient experienced oligomenorrhoea. In January 2011, the patient experienced amenorrhoea. On 25-MAY-2011, follicle-stimulating hormone (FSH) test revealed 108, which was abnormal. On 24-JUN-2011, Anti-mullerian hormone test revealed <1, which was abnormal. At the time of the report, the patient''s outcome was unknown. It was reported there there was reasonable possibility that the events might have been caused by the GARDASIL. Follow up information from a physician via CSL indicated that the 13 year old patient who had well established menses developed irregular menses and oligomenorrhoea following GARDASIL vaccinations. Her FSH was elevated at 108 U/L, anti mullerian hormone unrecordable (less than 1); thyroid, prolactin, full blood count (FBC), urea electrolytes and creatinine (uec), liver function tests (lfts), androgen profile B12, were all normal. Karyotype was 46XX. At the time of the report, the patient''s outcome was unknown. Follow-up information was obtained on a request by the Company from the agency (local reference #2011MSDA121, OPR285383) via a public case detail form concerning the 13 year old patient who on an unspecified date was vaccinated with a dose of GARDASIL (previous reported as "on 11-FEB-2008, 05-MAY-2008, 04-AUG-2008 were vaccinated with the first, second and third dose of GARDASIL, respectively"). On an unspecified date, the patient was experienced oligomenorrhoea- premature menopause after 2009 vaccine followed by amenorrhoea. The agency considered that the premature menopause was possibly related to GARDASIL. Follow up information was received from the physician concerning her female patient (currently aged 17 years) with no family history of premature menopause or significant history of disease who on 11-FEB-2008, 05-MAY-2008, 04-AUG-2008 were vaccinated with the first, second and third dose of GARDASIL, respectively. The patient experienced menarche at age 13 and had a regular cycle till April 2009 when her periods became irregular. She had two periods in April 2009 followed by some regular periods, then two periods in August 2009 and September 2009. The patient had no periods from September 2009 until January 2010. the patient then had one period, followed by very irregular light bleeds approximately the second monthly for the remainder of 2010. The patient then had one period in January 2011 followed by six months of amenorrhoea. She had smears of menstrual blood loss twice in June 2011 then p-v bleed in July 2011. She also experienced hot flushes. The patient was seen by a specialist - gynaecologist who confirmed "premature menopause" - premature ovarian failure. The physician stated that medical or surgical intervention will be required for the future. The patient was otherwise in good health. Results of laboratory tests as follows: On 25-MAY-2011, serum dehydroepiandrosterone sulfate test (DHEAS) was performed with the result of 5.8 umol/L, serum thyroid-stimulating hormone (TSH) was 1.4 mlUL and normal, iron and B12 levels were normal, hepatic function tests (LFTs)/serum urea, electrolytes and creatinine (UEC) were normal, serum luteinizing hormone test (LH) was 31 U/L, testosterone was 0.7 nmol/L, serum sex hormone-binding globulin (SHBG) was 53 nmol/L, prolactin was 128 mlUL and serum hemoglobin(Hb) test was 13.3. On 24-JUN-2011, erythrocyte sedimentation rate (ESR) level was 11, serum C-reactive protein (CRP) level was 1, Ovarian was negative, serum beta-human chorionic gonadotropin (Beta hcg) was below 2 and chromosome studies were 46 XX. On 06-JUL-2011, anti-Mullerian hormone was below 1.0pmol/L (low). In August 2011, galactosaemia screen negative and fragile X permutation screen was negative. Serological evidence of past infection from mumps either from vaccination or natural infection on 24-JUN-2011, normal pelvic ultrasound. At the time of the report, the patient had not recovered. The reporting physician considered that the patient''s "premature menopause" was possibly related to vaccination with GARDASIL. The reporting physician considered that he patient''s "premature menopause" was considered to be disabling due to infertility and other important medical event ("medical or surgical intervention will be required for the future"). Additional information is not expected.
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