Is Chronic Fatigue Syndrome/Myalgic Encephalomyelitis a Relevant Diagnosis in Patients with Suspected Side Effects to Human Papilloma Virus Vaccine?

The quad rivalent human papilloma virus vaccine (Q-HPV-vaccine) was included into the Danish childhood vaccination program in 2009. During the past years possible side effects have been described in several countries encompassing a collection of symptoms consistent with pronounced autonomic dysfunction coupled with severe non-migraine-like headache, excessive fatigue, cognitive dysfunction, gastrointestinal discomfort and widespread pain of a neuropathic character. The assessment of the prevalence and the possible pattern in symptoms suspected to be side effects has been hampered by a lack of consistency in the diagnostic criteria applied on seemingly similar symptom complexes. As fatigue and fatigability is a prominent symptom in many of the patients with suspected side effects to the vaccine, chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME)c ould be suspected to be a suitable diagnosis. We have performed a retrospective analysis on the applicability of the CFS/ME diagnosis in 39 patients referred to our Syncope Unit from May 2011 to April 2015 for clinical evaluation including a head-up tilt test. The patients were referred due to orthostatic intolerance and symptoms compatible with autonomic dysfunction occurring in a close temporal association to vaccination with the Q-HPV vaccine. We found that 34 (87%) and 35(90%) of the patients fulfilled the diagnostic criteria for CFS/ME regarding to the Canadian and the IOM (Institute of Medicine) criteria respectively and suggest that CFS/ME may be a suitable diagnosis for patients with severe and persistent suspected side effects to the Q-HPV vaccine. For the time being we can neither confirm nor dismiss a causal link between the vaccine and the disabling symptoms, but a consensus on the classification of the patients is needed in order to attain a more systematic clinical and scientific approach to this challenge. Common diagnostic criteria could hopefully result in a specific treatment protocol and thereby strengthen the worldwide program to combat cancers caused by human papilloma virus.