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<p>A total of 2,624 spontaneous suspected serious adverse reaction reports (ADRs)
with human papilloma virus (HPV) vaccines have been reported to the Medicines and
Healthcare products Regulatory Agency (MHRA) via the Yellow Card Scheme up to 7 July
2015.</p><p> </p><p><strong> </strong></p><p> </p><p>To date more than eight million
doses of HPV vaccine have been given in the United Kingdom since 2008, with close
to 90% eligible teenagers vaccinated. The vast majority of suspected side effects
reported so far relate to those we would expect with most types of vaccine; these
are most commonly dizziness, headache, nausea, sore arms, vomiting, general malaise,
tiredness, fever, and rashes. These tend to be mild and transient. Many serious reports
relate to immediate fainting, which is not necessarily a side effect of the vaccine
but a response that any type of needle insertion can provoke in some people.</p><p>
</p><p><strong> </strong></p><p> </p><p>The following table provides a breakdown of
UK suspected spontaneous ADRs received via the Yellow card Scheme in association with
all vaccines on the immunisation schedule. The table provides the total number of
reports, the total number of serious reports and the number of serious reports followed
up.</p><p> </p><p><strong> </strong></p><p> </p><p>UK suspected spontaneous ADRs received
via the Yellow card Scheme in association with all vaccines on the immunisation schedule.</p><p>
</p><p> </p><p> </p><p> </p><p> </p><p> </p><p> </p><p> </p><p> </p><table><tbody><tr><td><p>Vaccine
Brand</p></td><td><p>Total number of reports</p></td><td><p>Number of serious reports</p></td><td><p>Number
of serious reports followed up</p></td><td><p>% of serious reports followed up*</p></td></tr><tr><td><p>Human
Papilloma Virus (HPV)</p></td><td><p>8,276</p></td><td><p>2,624</p></td><td><p>441</p></td><td><p>17%</p></td></tr><tr><td><p>Diphtheria,tetanus,
pertussis, polio and <em>Haemophilus influenza </em>type b (DTaP/IPV/Hib)</p></td><td><p>1,382</p></td><td><p>713</p></td><td><p>103</p></td><td><p>14%</p></td></tr><tr><td><p>Tetanus,
diphtheria and polio (Td/IPV)</p></td><td><p>1,152</p></td><td><p>671</p></td><td><p>95</p></td><td><p>14%</p></td></tr><tr><td><p>Diphtheria,tetanus,
pertussis and polio (DTaP/IPV)</p></td><td><p>1,326</p></td><td><p>509</p></td><td><p>65</p></td><td><p>12%</p></td></tr><tr><td><p>Rotavirus
(Rotarix)</p></td><td><p>452</p></td><td><p>283</p></td><td><p>70</p></td><td><p>25%</p></td></tr><tr><td><p>Pneumococcal
disease (PCV)</p></td><td><p>1,611</p></td><td><p>882</p></td><td><p>85</p></td><td><p>10%</p></td></tr><tr><td><p>Meningococcal
group C disease (Men C)</p></td><td><p>14,671</p></td><td><p>4,241</p></td><td><p>81</p></td><td><p>2%</p></td></tr><tr><td><p>Hib/Men
C</p></td><td><p>285</p></td><td><p>155</p></td><td><p>23</p></td><td><p>15%</p></td></tr><tr><td><p>Measles,
mumps and rubella (MMR)</p></td><td><p>5,492</p></td><td><p>2,804</p></td><td><p>88</p></td><td><p>3%</p></td></tr><tr><td><p>Pneumococcal
disease (PPV)</p></td><td><p>1,726</p></td><td><p>985</p></td><td><p>27</p></td><td><p>3%</p></td></tr><tr><td><p>Fluenz/
Fluenz Tetra</p></td><td><p>877</p></td><td><p>381</p></td><td><p>74</p></td><td><p>19%</p></td></tr><tr><td><p>Zostavax</p></td><td><p>646</p></td><td><p>408</p></td><td><p>105</p></td><td><p>26%</p></td></tr><tr><td><p>Influenza
virus</p></td><td><p>5,745</p></td><td><p>3807</p></td><td><p>483</p></td><td><p>13%</p></td></tr></tbody></table><p>
</p><p>* Percentage provided to the nearest whole number</p><p> </p><p><strong> </strong></p><p>
</p><p>It should be noted that a Yellow Card report is not proof of a side effect
occurring, but a suspicion by the reporter that the vaccine may have been the cause.
Yellow Card data cannot be used as a reliable indicator of the frequency of suspected
ADRs to vaccines or medicines. The level of ADR reporting may fluctuate between given
years due to a variety of reasons such as a medicine being new (reporting rates are
generally higher when a product is first introduced), stimulated interest/publicity
and variations in exposure to the medicine. Comparisons of ADR reporting rates would
be an invalid estimate of relative vaccine safety.</p><p> </p><p> </p><p> </p><p>Every
reporter to the Yellow Card scheme receives an acknowledgement which asks that any
new information relating to the case be reported. Follow up procedures for Yellow
Card reports are in place and are designed to ensure that relevant information is
sought if this is missing from reports of serious reactions which could potentially
be new signals. While in an ideal world full details would be obtained for every report,
given there are over 750,000 reports on the database with around 30,000 new reports
each year, it will never be possible to ensure all reports on the database are complete.
There are a number of difficulties with achieving satisfactory follow up. Time pressure
on potential reporters has been identified as one of the reasons for under-reporting
adverse reactions through the Yellow Card Scheme. This issue also applies to requests
for follow up information and therefore there is a need to be selective and focussed
about the reports for which follow up information is requested.</p><p> </p><p> </p><p>
</p><p>The HPV vaccine has a very good safety record, and surveillance shows it has
contributed to a significant decrease in rates of infection with the two main cancer-causing
human papillomaviruses. The UK programme is eventually expected to prevent hundreds
of deaths from cervical cancer every year.</p><p> </p>
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