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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: This literature marketed report was received from the authors of a published literature article concerning a 29 year old female patient, enrolled in a retrospective study aimed to examine their experiences of side effects from the human papillomavirus (HPV) vaccine. The patient had no children and was a full time student. Her status before vaccination was reported as healthy. The patient started taking an unspecified antidepressant medicine one year before vaccination. On an unknown date, the patient received her first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (dose and route of administration were not reported). On an unknown date in 2012, the patient received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (dose and route of administration were not reported). On an unknown date, after the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(manufacturer unknown), the patient experienced side effects, which aggravated after the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(manufacturer unknown). The patient felt exceedingly physically and mentally confined in her everyday life, which led her to live a more restricted and solitary life. The patient decided not to get the last injection, due to the side effects that she experienced. All the women link their symptoms to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(manufacturer unknown) because they occurred soon after vaccination. Generally, the women tend not to perceive themselves as ill, but rather as more physically and mentally constrained than they were before having their vaccination. The lack of acceptance from family and friends has led the women to distance themselves from others and lead a more socially isolated life. The outcome of the event of side effects was not reported. This is one of several reports received from the same literature article (cross referenced with MARRS #1612DNK004981, #1612DNK004850, #1612DNK004996, #1612DNK004841, #1612DNK004650, #1612DNK004656, #1612DNK004576). Follow up information has been received from the author (physician) of the article on 19-JAN-2017. On an unknown date in 2012, the patient received the first dose of GARDASIL. On unknown date in 2012, the patient experienced side effects including muscle pain, fatigue, dizziness, sensory disturbances, low blood pressure, severe headache, respiratory distress and postural orthostatic tachycardia syndrome (POTS). Treatment for the events included changed diet. 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 events. Upon internal review, respiratory distress was considered to be medically significant. 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-009507513-1612DNK004588: DK-009507513-1612DNK004981: DK-009507513-1612DNK004850: DK-009507513-1612DNK004996: DK-009507513-1612DNK004841: DK-009507513-1612DNK004650: DK-009507513-1612DNK004656: DK-009507513-1612DNK004576.
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