Ireland: Adverse Reaction Reports for Gardasil 4 times the rate of next most reported vaccine

               -  more reactions than all other vaccines combined for girls. 

By Martin Healy,

Regret.ie, 12 Aug 2015.

REGRET.IE recently obtained from the Irish Health Regulatory Authority (HPRA) all the adverse reaction report files for ten shots (26 individual vaccines) on the childhood schedule covering a five year period up to the end of 2014. An analysis of the reports revealed that the number of Adverse Reaction Reports for the HPV Vaccine Gardasil (839 reports) are almost double those of the second most reported injection (the '4-in-1' shot with 428 reports). Since Gardasil is only given to girls, this equates to an adverse reaction rate that is 4 times that of the next most reported vaccine (given to both boys and girls).  This also means that the number of reactions reported for Gardasil is more than all the other vaccines combined for the same injected population size (assuming other vaccine reactions were reported at the same rate for both boys and girls) . 

According to the HPRA, "Spontaneous reporting of suspected ADRs (Adverse Drug Reactions) is an inexpensive and effective method for the lifetime surveillance of medicines" and "may contribute considerably to the assessment of a potential safety hazard". 

Up until 2012, reporting of suspected vaccine reactions in Ireland depended on the voluntary submission of a report from a doctor, consultant or medical professional. In 2012, online reporting became possible for a member of the public - although this option is still not widely known to the public. The incidence of adverse reactions is under-reported as most doctors will not acknowledge any connection between a vaccine and a subsequent serious medical condition that manifests in the weeks or months afterwards. At least that has been the experience of most of the 50 families who have shared their stories with the Support group REGRET*.  

Is the HPRA actively monitoring or investigating serious adverse reactions?

Despite HPRA claims in the media that they are 'actively monitoring' reports, there is no evidence of follow-up monitoring or investigation.  If the status of the case report happens to be "Not recovered at time of reporting", then that status will remain unchanged for all future reporting purposes.

When asked by this author if there was any procedure in place to follow up those reports whose 'Outcome' was "Not recovered at time of reporting", HPRA replied with the following statement:

"All reports received are reviewed and evaluated to see what, if any, additional information is important for the evaluation of a case and this is requested as part of our routine follow up of reports, as necessary and appropriate. However, it is not always possible to obtain further information".

Irish vaccine-injured victims - more than just a statistic?

There are no plans to introduce a vaccine compensation fund in Ireland and parents are financially responsible for those medical costs not covered by insurance or medical card. When questioned in the Dail recently, the MInister for Health avoided answering a question on whether vaccine makers have been granted immunity that protects them from litigation in the event of vaccine harm.

Although its cancer-preventing properties have never been proven, the National Immunisation Office insists that the benefits of Gardasil outweigh the risks, and even claim that it has been 'fully tested', This is despite the limited safety testing that took place as a result of Gardasil being fast-tracked through the regulatory approval process. HSE did not inform parents that Gardasil contains genetically engineered non-human recombinant DNA, the effects of which are unknown and unpredictable when injected into a human host.

Current status of adverse reactions to Gardasil in Ireland

The most recent HPRA report reveals 945 reports of suspected HPV vaccine adverse reactions from 2010 up to 16/07/2015. Of which 
- 83   "Outcome" is "Unknown" 
- 137 "Not recovered at time of reporting"
- 12   "Recovering"

*R.E.G.R.E.T. is an acronym for "Reactions and Effects of Gardasil Resulting in Extreme Trauma".

If your child has suffered health issues that you think may have been triggered by Gardasil, and you wish to get in contact with other parents who have had a similar experience, please contact us at: