FOI release

Freedom of Information request on Yellow Card reports for COVID-19 vaccinations (FOI 21/717)

Published 29 December 2021

23rd July 2021

FOI 21/717

Dear

Thank you for your email dated 24th June 2021, whereby you requested the following information:

1. For COVID-19 reports since the 9th December 2020 to June 9th 2021: A breakdown of the numbers of suspected ADRs that have been reported by healthcare professionals. Please break this down to include profession type and specific suspected ADR types, plus numbers reported by each type of profession.

2. For COVID-19 reports since the 9th December 2020 to June 9th 2021: A breakdown of the numbers of suspected ADRs that have been reported by members of the public. Please break this down to include member of the public type and specific suspected ADR types, plus numbers reported by each type of member of the public.

3. For COVID-19 reports since the 9th December 2020 to June 9th 2021: Information for Healthcare professional of what protocols have been employed to check the validity of individual reports of serious/fatal suspected ADRs

4. For COVID-19 reports since the 9th December 2020 to June 9th 2021: Information for Members of the Public` of what protocols have been employed to check the validity of individual reports of serious/fatal suspected ADRs

In response to question 1, please find below Table 1 which displays the total number of UK spontaneous suspected Adverse Drug Reaction (ADR) reports received directly by healthcare professionals to the Yellow Card Scheme in association with COVID-19 vaccines, including a breakdown by profession. Unfortunately, we are unable to provide a breakdown of the specific ADR type for each qualification. We consider that your request is covered by Section 22 of the Freedom of Information Act (information intended for future publication) and the information you have asked for is therefore exempt from disclosure. Section 22 is a qualified exemption which means we have considered whether there is a greater public interest in releasing the information requested or withholding it. We recognise there is strong interest in seeing this data and are working towards making this available in a publicly accessible format.

Table 1: Total number of UK spontaneous suspected COVID-19 vaccine reports by healthcare professional reporter between the reporting period of 9th December 2020 to June 9th 2021.

Qualification	Total
Community Pharmacist	656
GP	10834
Hospital Doctor	4567
Hospital Healthcare Professional	1397
Hospital Nurse	2856
Hospital Pharmacist	1160
Nurse	7558
Other Healthcare Professional	18653
Pharmacist	3053
Physician	810
Total	51544

*Including chiropodist, coroner, dentist, healthcare assistant, medical student, midwife, optometrist, reporters specifically described as ‘other healthcare professionals’, paramedic, pharmacy assistant, pre-reg pharmacist and radiographer.

The vaccines included in this data search were COVID-19 Vaccine AstraZeneca, COVID-19 Vaccine Pfizer/BioNTech, COVID-19 Vaccine Moderna, and those reports in which the brand of COVID-19 vaccine was not specified by the reporter.

Regarding your second question, between the reporting period of 9th December 2020 to 9th June 2021, 81% of spontaneous ADR reports were reported directly by patients or members of the public. 19% of the total reports received in this period were received by healthcare professionals. Please note that at the beginning of the vaccination programme, healthcare professionals were prioritised and therefore the number of reports from patients is considerably larger as many healthcare professionals who received the vaccine reported themselves as the patient. Unfortunately, we are unable to provide a breakdown of the specific ADR type for this reporter group as the same Section 22 exemption as described above applies. It is also important to note that the total number of reports in Table 1 will not equal the total number of reports received by healthcare professionals as some reports may have more than one reporter. The same report may have more than one reporter if, for example, two different healthcare professionals report the same case to us, these cases are subsequently merged. Please also note that the data within this response does not contain information on reports submitted by patients or healthcare professionals via the pharmaceutical company, only those reported directly to the MHRA via the Yellow Card Scheme.

The third and fourth questions within your request are regarding what protocols have been employed to check the validity of individual reports of serious/fatal suspected ADRs. Yellow Card reports require details of the reporter, a patient identifier (such as age, sex, initials or record number), a suspect medication/vaccine and adverse reaction details in order for it to be considered a valid report. As reports are reviewed, any reports that are suspected to have provided false reporter or patient information are followed up for confirmation. Any fake reports are removed from the database. The MHRA have a dedicated Enforcement Group who individuals can contact in confidence should they have concerns regarding fake ADR reporting.

Please be reassured that the MHRA takes all reports of adverse reactions with the utmost seriousness, including those reporting fatal events in patients who have received a COVID-19 vaccine. Where these events are reported to us, we follow up to find out full details of the events, the cause of death and, where applicable, further information of any post-mortem findings. Additionally, if a discrepancy is noted in a Yellow Card report we can follow-up with the reporter for confirmation of the information provided. We are dedicated to ensuring our online reporting tool is as easy as possible for people to use. We encourage everyone to report suspected adverse reactions to the scheme and patient safety is our highest priority.

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