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Life Threatening? No
Write-up: This literature marketed report has been received from a health professional referring to a 44 year old female patient. The patient had 3 children. The patient was healthy. 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. In-depth qualitative interviews were conducted with eight HPV-vaccinated Danish women, aged 25-44 years, who experienced side effects from the vaccine. The data were analysed using a narrative methodology. 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. 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 Danish 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 3 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 third dose in 2013, start date of other two doses 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 injections 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). Follow up information was received from the author of the literature article entitled as stated below. This literature marketed report as received from a other health professional refers to a 44 year old female patient. In 2013 the patient was vaccinated with a dose of GARDASIL dose 3 (site, route and lot number not reported) for prophylaxis. In 2013, the patient experienced postural orthostatic tachycardia syndrome (POTS), migraine, dizziness, respiratory distress, muscle tension, palpitations, memory problems, fever, rash, fatigue and hot flashes. The outcome of respiratory distress, fatigue, rash, pyrexia, dizziness, migraine, palpitations, memory impairment, muscle tightness, hot flush and POTS was reported as worsened. The reporter considered postural orthostatic tachycardia syndrome, hot flush, fatigue, rash, pyrexia, memory impairment, palpitations, muscle tightness, respiratory distress, dizziness and migraine to be related to GARDASIL. The author considered POTS, migraine, dizziness, respiratory distress, muscle tension, palpitations, memory problems, fever, rash, fatigue and hot flashes serious as disability (also reported as "longer or permanent unfitness for work"). Upon internal review respiratory distress was considered serious as medically significant. Literature report: A qualitative study of women who experience side effects from human papillomavirus vaccination. This is one of several cases received from the same literature article (1612DNK004588, 1612DNK004996, 1612DNK004841, 1612DNK004850, 1612DNK004650, 1612DNK004576). Additional information is not expected
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