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Life Threatening? No
Write-up: This literature marketed report has been received from a health professional referring to a 41 year old female patient. The patient had 4 children. The patient was healthy. INTRODUCTION: Vaccination against human papillomavirus (HPV) was offered to girls and women to prevent cervical cancer. Unfortunately, reporting of possible side effects from vaccination had increased in recent years. Therefore, the present study examined women''s experiences of side effects from the HPV vaccine. METHODS: In-depth qualitative interviews were conducted with eight HPV-vaccinated women, aged 25-44 years, who experienced side effects from the vaccine. The data were analysed using a narrative methodology. RESULTS: The main reasons for being vaccinated against HPV were fear of cancer and trust in general practitioners (GPs). The women reported feeling stigmatised by GPs and doctors and they felt that these professionals did not acknowledge their symptoms, often assuming that they were due to psychological distress. The lack of acceptance from family and friends had led the women to distance themselves from others and led a more socially isolated life. The women believed that a diagnosis might validate their symptoms and helped others accept their condition. CONCLUSIONS: The women feel exceedingly physically and mentally confined in their everyday life, which led them to live a more restricted and solitary life. Since other people tended not to acknowledge their symptoms, the women''s illness behaviour was poorly accepted. The women generally distrust healthcare as they had experienced stigmatization from physicians and did not trust the evidence for the safety of the vaccine. The patient was vaccinated with 2 injections of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufactured unknown) (dose, route and lot# not reported) for prophylaxis (start date of the second dose in 2013, start date of the first dose unspecified). Concomitant therapy was not reported. After 1st injection on an unknown date the patient experienced adverse effects. The adverse effects aggravated after the next injection of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufactured unknown). The outcome of adverse effects was unknown. The reporter considered adverse event to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufactured unknown). This is one of several reports from the same literature (MARRS #1612DNK004981, 1612DNK004850, 1612DNK004588, 1612DNK004841, 1612DNK004650, 1612DNK004656 and 1612DNK004576). Follow up information has been received from the author of the article on 19-JAN-2017. On an unknown date in 2013, the patient received the first dose of GARDASIL. On an unknown date in 2013, the patient experienced the adverse effects including severe headache, memory problems, postural orthostatic tachycardia syndrome (POTS), dizziness, low blood pressure and fatigue. The outcome was reported as worsened. Seriousness criteria were reported as: "Longer or permanent unfitness for work" and "disability". The author did not have any additional information about the adverse effects. Additional information is not expected as the reporter has no further information. Reporter, lab test, product, event and narrative were updated. Sender''s Comments: DK-009507513-1612DNK004981: DK-009507513-1612DNK004576: DK-009507513-1612DNK004650: DK-009507513-1612DNK004656: DK-009507513-1612DNK004841: DK-009507513-1612DNK004850.
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