Freedom of Information request on all reactions reported via the Yellow Card scheme for the combination DTaP/IPV/Hib/HepB vaccine (FOI 21-342)
Published 28 June 2021
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5th May 2021 FOI 21/342
Thank you of your email dated 2nd April 2021, where you requested data on all reactions reported via the Yellow Card scheme for the combination DTaP/IPV/Hib/HepB vaccine, particularly with regards to the development of scoliosis.
Please find enclosed Drug Analysis Prints (DAPs), which list all reported, suspected reactions associated with the combination DTaP/IPV/Hib/HepB vaccine up to and including 19/04/2021. Please refer to the attached information sheet for guidelines on how to interpret the DAP. Of all the reports received, none included scoliosis as a suspected reaction.
When considering the attached spontaneous ADR data, it is important to be aware of the following points: • A reported reaction does not necessarily mean it has been caused by the vaccine, only that the reporter had a suspicion it may have. Each year, millions of doses of routine vaccinations are given in the UK alone, and when any vaccine is administered to large numbers of people, some recipients will inevitably experience illness following vaccination. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.
• Additionally, the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction or compare the safety profile of different vaccines. As this data does not necessarily refer to proven side effects, you should refer to the product information (Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL)) for details on the possible side effects of each influenza vaccine, which can be found here: Home - electronic medicines compendium (emc)
I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.
Yours sincerely, FOI Team, Vigilance and Risk Management of Medicines Division