HPV vaccine under-reported adverse events

PROTOCOL FOR A COCHRANE REVIEW (INTERVENTION)

Djurisic, Jakobsen et al.

Aluminium adjuvants used in vaccines versus placebo or no intervention

Cochrane Database of Systematic Reviews | Protocol - Intervention

Version published: 24 September 2017

DOI: https://doi.org/10.1002/14651858.CD012805

Since the US approval of Gardasil® in 2006 and up until 2012, a total of 21,265 adverse events was reported to the national Vaccine Adverse Event Reporting System (VAERS) (Tomljenovic 2012). HPV vaccines have been blamed for giving rise to more reported adverse events than other types of vaccines (Tomljenovic 2012).

The symptoms reported following HPV vaccination are varied and include headache, orthostatic intolerance, fatigue, cognitive dysfunction, blurred vision, feeling bloated, abdominal pain, light sensitivity, and involuntary muscle activity (Brinth 2015a; Brinth 2015b). Despite the consistency in reported symptoms, they do not fit into a well‐defined category of diseases or diagnoses, but rather present themselves as a constellation of nonspecific symptoms (Brinth 2015a; Brinth 2015b). Consequently, the observational studies, which based their results on registered diagnoses, may have excluded an important fraction of eligible participants with unclear adverse symptoms, as most young girls that claim to suffer from adverse events following HPV vaccination receive no clinical diagnosis, and are therefore unlikely to appear in medical registers. Moreover, the randomised clinical trials on HPV vaccines, which formed the basis for the safety assessment, have been blamed for not using true placebo (e.g. placebo not containing adjuvants) as the control intervention (Exley 2011).