FOI release

Freedom of Information request (FOI 22/1021)

Published 17 January 2024

4th November 2022

FOI 22/1021

Dear

Thank you for your Freedom of Information request dated 7th October 2022, where you asked the following:

1. Number of people reporting autoimmune issues that they suspect are due to, or have been made worse by, a COVID vaccine. I specifically want the number of reports made irrespective of the outcome of investigation. For further avoidance of doubt, conditions that have autoimmune reaction as a possible cause of a suspect cause should be counted in these figures.

2. The number of these reports that been confirmed, rejected or are currently being investigated (separate figured for each, not a combined figure for all). For thought that have been rejected, I would like it subdivided into rejected after investigation and rejected without investigation.

If possible, I would like the information to be broken down by vaccination date. Simple month by month or even 3-month periods are fine. However, if the data are not available broken down by date, the overall data will be sufficient.

Further to your request we have searched our database for UK spontaneous suspected Yellow Card reports received up to and including 25th October 2022 associated with any COVID-19 vaccine reporting a reaction which falls under the ‘immune-mediated/ autoimmune disorders’ group within our medical dictionary. A list of the terms included can be found in Annex 1.

Please find Table 1 below as per your request, displaying the number of reports for each COVID-19 vaccine by the month in which the report was received by the MHRA. Where we have less than five reports this is marked with an asterix to ensure patient confidentiality is maintained and does not indirectly identify individuals.

Table 1: The number of reports for COVID-19 vaccines reporting a reaction within the immune-mediated/ autoimmune disorders group up to and including 25th October 2022.

Month and year received	COVID-19 Pfizer vaccine	COVID-19 AstraZeneca vaccine	COVID-19 Moderna vaccine	COVID-19 vaccine unknown brand
December 2020	7	0	0	0
January 2021	45	16	0	0
February 2021	106	2422	*	0
March 2021	164	483	5	0
April 2021	156	540	*	6
May 2021	137	460	5	6
June 2021	125	312	6	12
July 2021	112	243	*	21
August 2021	90	134	0	19
September 2021	97	114	*	8
October 2021	101	83	*	7
November 2021	117	108	*	13
December 2021	122	104	*	44
January 2022	120	76	*	31
February 2022	822	42	*	18
March 2022	66	34	*	20
April 2022	43	30	*	11
May 2022	49	22	5	27
June 2022	39	23	0	15
July 2022	16	23	*	15
August 2022	31	16	*	6
September 2022	22	12	*	12
October 2022	30	10	*	14
Total	1877	3127	305	55

When considering the attached spontaneous Yellow Card 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. 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.

• 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. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular medicine, and may be stimulated by promotion and publicity about a drug.

You also asked how many of these reports have been confirmed, rejected or are currently being investigated. All Yellow Card reports we receive are promptly entered onto the MHRA’s Adverse Drug Reaction (ADR) database so that they are available for a process called signal detection. During signal detection, reports are evaluated, together with additional sources of evidence, by a team of safety experts. For this reason, each report we receive is valuable as it may represent a previously unrecognised side effect. We apply statistical techniques that can tell us if we are seeing more events than we would expect to see, based on what is known about background rates of illness in the absence of medication or vaccination. This aims to account for factors such as coincidental illness. We also look at the clinical characteristics to see if new patterns of illness are emerging that could indicate a new safety concern. Therefore, no report is rejected and each report is added on our database and fully assessed.

All our reports can be viewed from our Coronovirus (COVID-19) vaccines summary page which includes Vaccines Analysis Prints (VAPs) and associated product information for each COVID-19 vaccination https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions

For further information on how we use the data we collect, please view our COVID-19: vaccine surveillance strategy - GOV.UK (www.gov.uk)

As mentioned above, Yellow Card reports are not proof of a side effect occurring due to a vaccine but a suspicion by the reporter that the vaccine may have caused the side effect. Some events may have happened naturally, regardless of vaccination. For example, sometimes, these events can be part of the condition being treated rather than being caused by the vaccine. This is particularly the case when millions of people are vaccinated.

I hope the information provided is helpful; however, 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