FOI release

Freedom of Information request on how many women have had the COVID-19 vaccine, paroxysmal extreme pain disorder and cases of spontaneous abortion (FOI 21-594)

Published 13 August 2021

29th June 2021 FOI 21/594

Thank you for your email dated 31st May 2021, where you requested:

• Approximately how many women in the UK have been vaccinated with a covid-19 vaccine?

• According to the Yellow Card data up to 19th May 2021, 134 cases of spontaneous abortion were reported with 1 fatality. Please can you confirm whether this was a maternal death and what the cause of death was?

• The age and gender of the 11 individuals with the reported rare condition ‘Paroxysmal Extreme Pain Disorder’?

Firstly, regarding your question about how many women in the UK have been vaccinated with a COVID-19 vaccination, Public Health England hold this information and have published interactive graphs and tables on the number of people have been vaccinated which is available here: https://coronavirus.data.gov.uk/details/vaccinations. You can contact them directly for a breakdown by age and gender: https://www.gov.uk/government/organisations/public-health-england.

I can confirm as of the 19th May 2021, in terms of the spontaneous abortion reports we’ve received in association with the AstraZeneca vaccination the one fatal case in question was not a maternal death but referred to a first trimester miscarriage. By convention, miscarriages prior to 22 weeks are not classified as fatal as the event relates to the mother rather than the foetus. Please note we routinely review and update cases to ensure information is accurately captured on our database so published numbers may change over time. This case has since been reclassified on our database accordingly, which you may be able to see from the Vaccine Analysis Prints published in the latest weekly COVID-19 vaccine summaries, https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions

Sadly, miscarriage is estimated to occur in about 1 in 4 pregnancies in the UK (outside of the pandemic) and most occur in the first 12 weeks (first trimester) of pregnancy, so some miscarriages would be expected to occur following vaccination purely by chance. There is currently no pattern to suggest an elevated risk of miscarriage related to exposure to the COVID-19 vaccines in pregnancy. The MHRA continues to closely monitor reports of vaccine exposure in pregnancy. If any further data or evidence becomes available which suggests these vaccines are unsafe for use in pregnancy, this will be reviewed as soon as possible by our assessors and independent expert committee advisors.

Regarding your final point up to and including the 16th June 2021 we have received 12 spontaneous ADR reports of Paroxysmal Extreme Pain Disorder with the AstraZeneca COVID-19 vaccine. All Yellow Card reports are reviewed and fully evaluated by the MHRA. Upon assessment of these reports, all were found to be related to adult patients that described body pain including arm pain, muscle and joint pain or general body aches, including reports of ‘extreme pain’, rather than medically confirmed cases of Paroxysmal Extreme Pain disorder. All these reports were submitted by patients and as such have selected the reaction terms, they believe best describes their experience.

We are dedicated to ensuring our online reporting tool is as easy as possible for users. If a mis-selection is noted in a Yellow Card report we can follow-up with the reporter for confirmation if necessary, where permission allows. We routinely review and update cases to ensure information is accurately captured on our database so published numbers may change over time.

It is important to note that a reported reaction does not necessarily mean it has been caused by the vaccine, only that the reporter had a suspicion it may have. The fact that symptoms occur after use of a vaccine or medicine and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by it. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.

We are unable to provide details on age and gender of the individuals who report Paroxysmal Extreme Pain Disorder at this time. This is because we intend to publish all suspected reactions reported in association with available COVID-19 vaccines in an interactive format as an interactive Drug Analysis Profiles (iDAPs), along with our ADR summary that is published each week. The use of iDAPs will enable users to view the data by categories of their choice such as age, sex, and seriousness of reports. As we plan to publish the data, we consider that your request is covered by Section 22 of the Freedom of Information Act (information intended for future publication). Unfortunately, we are unable to provide an exact date as to when iDAPs (interactive Drug Analysis Profiles) will be published. We recognise that there is strong interest in seeing this data and accept it should not be withheld indefinitely. Please be assured that we will send you the link to the iDAPs as soon as they are available.

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