FOI release

Freedom of Information request on adverse reactions reported relating to the COVID-19 vaccine for the Merseyside region (FOI 22/376)

Published 27 March 2023

FOI 22/376

13th May 2022

Dear

FOI request MHRA Yellow card reports

Thank you for your email correspondence with our FOI team on the 19th January 2022 and please accept our sincerest apologies for the delay in responding to your FOI request whilst the MHRA responds to a high volume of similar requests. It was noted in your email that you specifically requested the following:

• Please provide data and information for the Merseyside region as they relate to the COVID-19 vaccines.

• Please state the number of MHRA Yellow Card Reports of deaths reported against all Government-approved COVID-19 vaccines broken down by reporter qualification and year of receipt (2020-2021).

• Please state the number of MHRA Yellow Card Reports of adverse reactions reported against all Government-approved COVID-19 vaccines broken down by reporter qualification and year of receipt (2020-2021).

Following a search of our database up to and including 31st December 2021, I can confirm that the MHRA have received 7330 spontaneous suspected Adverse Drug Reaction (ADR) reports associated with the COVID-19 vaccinations, reported from the Merseyside region (including NHS Knowsley CCG, NHS Liverpool CCG, NHS Southport and Formby CCG, NHS South Sefton CCG, NHS St Helens CCG, and NHS Wirral CCG, which cover the requested postcodes). Further to your request, of these 7330 reports, 37 reports concern a fatal outcome suspected to be associated with COVID-19 vaccine administration. The Government-approved COVID-19 vaccines include:

• COVID-19 Vaccine Pfizer/BioNTech

• COVID-19 Vaccine Oxford/AstraZeneca

• COVID-19 Vaccine Moderna

For completeness, we have included reports from the Merseyside region where brand of vaccine has not been specified. The COVID-19 vaccine Janssen and COVID-19 vaccine Novavax have additionally been authorised for use within the UK. However, they are not currently available and not being used in the ongoing vaccination programme.

The data included within this FOI response has been extracted based on reporter postal code. It is therefore important to note that the accuracy of this data relies on the postcode correctly being provided by the reporter in the original Yellow Card. The provision of postal addresses are not required to submit a valid report; reporters are required only to provide a contactable address which can be either an email address or postal address. If reporters only provided an email address, these will not have been included in this analysis. As the data has been extracted using available postal addresses only, it may not reflect the true incidence of reporting following COVID-19 vaccination reported from Merseyside. Please see Table 1 and Table 2 below for a breakdown of the number of reports received from Merseyside broken down by reporter qualification and year of receipt for all UK licenced COVID-19 vaccines.

Due to the nature of a Yellow Card report, we are unfortunately unable to differentiate between professional and personal carers, so this has been greyed out within Tables 1 and 2. We are constantly looking for ways to improve our reporting system and the available options for reporter qualifications are under review as we look to be more diverse and include more specific options, such as professional carer and personal carer. Where the reporter qualification of ‘Carer’ has been selected by the reporter, these have contributed to the ‘Member of the Public’ case counts. A single ADR report may also have multiple reporters associated with it in circumstances where it is received from several sources. Therefore, the overall number of reports below does not necessarily equate to the total number of ADR reports received.

Please note that a number of selectable reporter qualifications are included in the overarching ‘Member of the Public’ group, including patient, parent, carer, consumer or other non-healthcare professional.

Table 1: UK Spontaneous suspected ADR reports received up to and including 31st December 2021, from Merseyside in association with COVID-19 vaccines that report a fatal outcome.

	DEATHS REPORTED TO MHRA YELLOW CARD FOR COVID-19 VACCINES
	2020	2021
Member of the Public (TOTAL)	-	15
Healthcare Professional (TOTAL)	*	21
- Professional Carer
- Community Pharmacist	-	-
- Coroner	-	*
- Dentist	-	*
- GP	-	*
- Hospital Doctor	-	10
- Hospital Health Professional	-	-
- Hospital Nurse	-	-
- Hospital Pharmacist	-	-
- Nurse	*	5
- Optometrist	-	-
- Other Health Care Professional	-	-
- Pharmacist	-	-
- Physician	-	-
- Lawyer	-	-
- Chiropodist	-	-
- Paramedic	-	-
- Radiographer	-	-
- Pharmacy Assistant	-	-
- Medical Student	-	-
- Midwife	-	-
- Healthcare Assistant	-	-
- Pre-Registered Pharmacist	-	-
PERSON TYPE UNKNOWN	-	*

Table 2**: UK Spontaneous suspected ADR reports received up to and including 31st December 2021, from Merseyside in association with COVID-19 vaccines.

	ADVERSE REACTIONS REPORTED TO MHRA YELLOW CARD FOR COVID-19 VACCINES
	2020	2021
Member of the Public (TOTAL)	10	5805
Healthcare Professional (TOTAL)	45	1475
- Professional Carer
- Community Pharmacist	-	28
- Coroner	-	*
- Dentist	-	54
- GP	6	279
- Hospital Doctor	*	147
- Hospital Health Professional	*	50
- Hospital Nurse	13	83
- Hospital Pharmacist	7	58
- Nurse	*	180
- Optometrist	-	-
- Other Health Care Professional	10	373
- Pharmacist	-	101
- Physician	-	5
- Lawyer	-	-
- Chiropodist	-	*
- Paramedic	-	9
- Radiographer	-	24
- Pharmacy Assistant	*	33
- Medical Student	-	24
- Midwife	-	13
- Healthcare Assistant	-	-
- Pre-Registered Pharmacist	-	11
PERSON TYPE UNKNOWN	-	-

*Where there were fewer than 5 reports per cell, we have not provided the data in order to protect reporter confidentiality and prevent identification of the reporters. **Case counts presented in Table 1 are also included within Table 2 as fatal outcomes have been attributed to suspected ADRs.

It is also important to note when reviewing the above data that healthcare professionals can submit reports on behalf of themselves and in turn may report their ‘reporter qualification’ as either their profession, or indeed as a patient, which may reduce the accuracy of these totals.

When considering the 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 vaccines are given in the UK alone, and when any vaccine is administered to very large numbers of people, some recipients will inevitably experience illness following vaccination. The fact that symptoms or events occur after use of a vaccine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by the vaccine. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.

• It is also important to note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions. Therefore, Yellow Card data cannot be used to determine the incidence of a reaction or to compare the side effect profiles of different medicines or vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug or vaccine and may be stimulated by promotion and publicity about a drug. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.

The MHRA takes all reports of serious and fatal events in patients who have received a COVID-19 vaccine very seriously. Every report with a fatal outcome is fully evaluated and kept under continual review. We follow up reports with a fatal outcome for further information, including post-mortem details if available. All details within a report are thoroughly assessed by a team of multidisciplinary medical and scientific assessors to consider whether the vaccine may have caused the event, or whether the event and fatal outcome were likely to be purely coincidental and due to underlying illness. We would like to reassure you that the information is thoroughly analysed for patterns or evidence which might suggest a causal link between vaccination and the serious event/death alongside data available from international sources, as well as the data being further considered by the Commission on Human Medicine and its Expert Advisory Groups. Any emerging evidence relating to possible risks associated with vaccines and medicines alike, are carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed and communicated with the public with the upmost importance.

I would like to take this opportunity to draw your attention to the Coronavirus vaccine – weekly summary of Yellow Card reporting, which is updated weekly and available here. This document may be of use to you as contains details of all ADR reports pertaining to the COVID-19 vaccines received via the Yellow Card Scheme, as well as summaries of our assessment so far on particular safety topics surrounding the COVID-19 vaccinations and break, as well as some detail on patient demographics. Unfortunately, this data is not broken down by location but does provide an overview of all reports received.

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