Suspected side effects to the quadrivalent human papilloma vaccine, Gardasil

By Louise Brinth1, 2, Ann Cathrine Theibel1, 2, Kirsten Pors1, & Jesper Mehlsen1, 2

1) Coordinating Research Centre/Syncope Unit, Grederiksberg Hospital; 2) Department of Clinical Physiology and Nuclear Medicine, Frederiksberg Hospital, Denmark


Introduction: The quadrivalent vaccine that protects against human papilloma virus types 6, 11, 16 and 18 (Q-HPV vaccine, Gardasil) was included into the Danish childhood vaccination programme in 2009. During the past years, a collection of symptoms primarily consistent with sympathetic nervous system dysfunction have been described as suspected side effects to the Q-HPV vaccine.

Methods: We present a description of suspected side effects to the Q-HPV vaccine in 53 patients referred to our Syncope Unit for tilt table test and evaluation of autonomic nervous system function.

Results: All patients had symptoms consistent with pronounced autonomic dysfunction including different degrees of orthostatic intolerance, severe non-migraine-like headache, excessive fatigue, cognitive dysfunction, gastrointestinal discomfort and widespread pain of a neuropathic character.

Conclusion: We found consistency in the reported symptoms as well as between our findings and those described by others. Our findings neither confirm nor dismiss a causal link to the Q-HPV vaccine, but they suggest that further research is urgently warranted to clarify the pathophysiology behind the symptoms experienced in these patients and to evaluate the possibility and the nature of any causal link and hopefully establish targeted treatment options.

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