Yellow card data, who reviewed it

Summary

The requester sought correspondence and governance details regarding Yellow Card data and COVID-19 vaccine adverse reactions between December 2020 and December 2021. The Cabinet Office responded with partial information, providing specific email exchanges from April 2021 concerning a death and anaphylaxis incident, while noting that not all requested information was held.

Key Facts

• The request was clarified to cover the period between December 2020 and December 2021 inclusive.
• The outcome was 'Some information sent but not all held'.
• Disclosed emails show a mix-up between a death following a Pfizer vaccination and a separate anaphylaxis Yellow Card incident.
• Minister David Ashford and Kathryn Magson discussed the appropriate public statement regarding the unconfirmed cause of death.
• The response included 9 pages across 2 documents.

Data Disclosed

• 2023-10-16
• 2023-11-14
• December 2020
• December 2021
• 15 April 2021
• 25 November 2021
• 23 October 2023
• 9 pages
• 2 documents
• FOI 21/401
• Tynwald Question 3.3

Original Request

Hi, It is unclear which board/sub-committee/dept/etc reviewed yellow card data for the Isle of Man. Please provide: 1. All correspondence between DHSC, DfE, Manxcare and Cabinet Office (inc Public Health) related to MHRA, Pharmacovigilance, Yellow Card, incidents and adverse reactions to the Covid vaccination sent and received during the months of December 2020 and December 2021. 2. All information used (including correspondence) to prepare Minister Ashford's response to the Tynwald Question 3.3. COVID vaccination - Issues reported through the yellow card system which was answered in the Tynwald sitting of 15 April 2021. 3. Kathryn Magson confirmed via email on 25 November 2021, that FOI 21/401 'has gone through the vaccination governance processes'. I have not seen this FOI discussed in minutes of the vaccine board under DHCS/Manxcare. - Please clarify what the 'vaccination governance processes' are and provide documents relating to that process? - If not already answered, please state which committee/sub-committee/dept/board was responsible for discussing and reviewing yellow card information. Please provide minutes of those groups. On the 23 October 2023 we wrote to ask you for clarification of your request: In order to identify and locate the information that you have asked for we need some further information from you. In particular, it would be helpful to know where you have stated in the first part of your request: "1. All correspondence between DHSC, DfE, Manxcare and Cabinet Office (inc Public Health) related to MHRA, Pharmacovigilance, Yellow Card, incidents and adverse reactions to the Covid vaccination sent and received during the months of December 2020 and December 2021" Are you asking for information for those two months specifically, or are you requesting information for the period between December 2020 and December 2021 inclusive? On 23 October you provided clarification as follows: "'Hello, no all months between dec 2020- dec 2021. Thank you"

Data Tables (2)

Full Response Text

From: Kathryn.Magson@gov.im To: Will.Greenhow@gov.im Sent: Thu Apr 15 2021 12:06:51 BST Subject: FW: URGENT INFO PLEASE

From: Magson, Kathryn
Sent: 15 April 2021 12:05 To: Ashford, David (MHK) David.Ashford@gov.im;

Subject: RE: URGENT INFO PLEASE

Hi

I am trying to see if the coroner has signed the death certification yet, but ultimately at the moment suggest we should be saying –

We are aware of an individual who sadly passed away last week They had had their vaccination earlier that day (which we have to say now I think, but don’t think we should be talking about this more broadly) The cause of death is not known at this stage as this may sadly have been due to underlying conditions.
The DHSC are assured that the relevant yellow card protocols have been followed in relation to the vaccine.
Continue to state that the risks of not having a vaccine etc…….

That’s all I would say for now? Just my thoughts on this for now. Meanwhile will check in around the coroner position.

Regards

Kathryn

From: Ashford, David (MHK) David.Ashford@gov.im
Sent: 15 April 2021 11:57 To: ; Magson, Kathryn Kathryn.Magson@gov.im Subject: RE: URGENT INFO PLEASE

Actually I didn’t say they died after an adverse reaction to the vaccine. I stated clearly we should not jump to conclusions that the two events are linked and that there currently was no proven link as will be shown when the Hansard is published.

Hon. David Ashford MHK Minister for Health & Social Care MHK for Douglas North Legislative Buildings Finch Road Douglas Isle of Man IM1 3PW British Isles Mobile | (07624) 427232 David.ashford@gov.im | www.tynwald.org.im | www.davidashford.im The House of Keys, a branch of Tynwald, the oldest continuous parliament in the world. The House of Keys is the elected branch of the Manx Parliament. The Isle of Man is an independent nation with its own laws, legislation and police force. It also has its own unique, very special and world renowned culture, language, history, heritage, wildlife and countryside.

From:

Sent: 15 April 2021 11:47 To: Magson, Kathryn Kathryn.Magson@gov.im; Ashford, David (MHK) David.Ashford@gov.im Subject: RE: URGENT INFO PLEASE

Hi thanks Kathryn, This is what the Manx Radio story says – if it’s wrong I’ll have to ask them to take it down but will need to give a statement putting the record straight:
The Health Minister has confirmed a person died after an adverse reaction to a COVID-19 vaccine. David Ashford confirmed the death in this morning's sitting of the House of Keys. They suffered anaphylaxis and subsequently passed away. Mr Ashford says it’s important to consider it could have been as a result of another underlying health condition rather than purely being administered with a vaccine:

From: Magson, Kathryn Kathryn.Magson@gov.im
Sent: 15 April 2021 11:43 To: Ashford, David (MHK) David.Ashford@gov.im;

Subject: RE: URGENT INFO PLEASE

Hi All

There has been a mix up here.

There hasn’t been a death in relation to anaphylaxis – that was a separate issue - a yellow card, and this was followed through. All protocols worked. Patient discharged.

The death was following Pfizer, cardiac arrest at home – but we don’t have the outcome of the post mortem to know if this is linked at all. In fact it is highly likely that it might not be linked. We really shouldn’t be talking about this individual as we don’t have their consent and we don’t know all the information about this case as yet. The coroner will need to decide – haven’t been advised that this was the case but can ask.

I am not sure where Daphne Caine is picking up the issues around a death re anaphylaxis.

Regards

Kathryn

From: Ashford, David (MHK) David.Ashford@gov.im
Sent: 15 April 2021 11:30 To: ; Magson, Kathryn Kathryn.Magson@gov.im Subject: RE: URGENT INFO PLEASE

I had thought for some reason there were comms ready somewhere on this in case it came up?

From:

Sent: 15 April 2021 11:29 To: Ashford, David (MHK) David.Ashford@gov.im; Magson, Kathryn Kathryn.Magson@gov.im Subject: RE: URGENT INFO PLEASE

Thanks Minister, I know prompted by a Q

I need to get something out ASAP, even if only the most basic conformation.

Kathryn, can you give me the basics as per highlighted below plz?

Thx

From: Ashford, David (MHK) David.Ashford@gov.im
Sent: 15 April 2021 11:26 To: ; Magson, Kathryn Kathryn.Magson@gov.im Subject: RE: URGENT INFO PLEASE

Unfortunately Daphne left me with no choice but to put it out there as I couldn’t mislead the House when she asked if I had any knowledge of a death.

Hon. David Ashford MHK Minister for Health & Social Care MHK for Douglas North Legislative Buildings Finch Road Douglas Isle of Man IM1 3PW British Isles Mobile | (07624) 427232 David.ashford@gov.im | www.tynwald.org.im | www.davidashford.im The House of Keys, a branch of Tynwald, the oldest continuous parliament in the world. The House of Keys is the elected branch of the Manx Parliament. The Isle of Man is an independent nation with its own laws, legislation and police force. It also has its own unique, very special and world renowned culture, language, history, heritage, wildlife and countryside.

From:

Sent: 15 April 2021 11:24 To: Ashford, David (MHK) David.Ashford@gov.im; Magson, Kathryn Kathryn.Magson@gov.im Subject: URGENT INFO PLEASE

Hi,

Could I have some information please about the patient death from anaphylaxis?

I’m being bombarded with media queries since Minister spoke in Keys.

I’ll need for a statement where / when the person passed away. Age and sex. How long after having had the jab. Next steps for reporting etc

Which vaccine won’t be a secret for long even if we don’t say.

Thanks

From:

Sent: 15 April 2021 11:00 To:

Subject:

Caution: This email is from an external sender. Please take care before opening any attachments or following any links.
Hello,

Are you asking for information for those two months specifically, or are you requesting information for the period between December 2020 and December 2021 inclusive?”

On 23 October you provided clarification as follows:

"'Hello, no all months between dec 2020- dec 2021.

Thank you""

While our aim is to provide information whenever possible, in this instance the Cabinet Office does not hold some of the information that you have requested.
Our response to your request in respect of the information that Cabinet Office does hold is as follows: 1. All correspondence between DHSC, DfE, Manxcare and Cabinet Office (inc Public Health) related to MHRA, Pharmacovigilance, Yellow Card, incidents and adverse reactions to the Covid vaccination sent and received during the months of December 2020 and December 2021.

Please see the attached documentation, held by Public Health at Appendix 1.

1. All information used (including correspondence) to prepare Minister Ashford's response to the Tynwald Question 3.3. COVID vaccination - Issues reported through the yellow card system which was answered in the Tynwald sitting of 15 April 2021.

Please see the attached email exchange at Appendix 2.

1. Kathryn Magson confirmed via email on 25 November 2021, that FOI 21/401 'has gone through the vaccination governance processes'. I have not seen this FOI discussed in minutes of the vaccine board under DHSC/Manxcare.

The Cabinet Office does not hold information in this regard, however you may wish to submit a freedom of information request in this regard to DHSC and/or Manx Care.

While our aim is to provide information whenever possible, in this instance, some of the information contained in the supplied records are exempt from disclosure to you. Redaction has been applied where the following exemption, allowed under the act, has been assessed and engaged:

Section 25(2)(a)and (b)(i) – Absolutely exempt personal information

The reasons why that exemption applies are that: • Cabinet Office is satisfied that in such cases the information amounts to personal data of which you are not the data subject; and • Cabinet Office is satisfied that disclosure of the information would contravene one of the data protection principles as set out at Article 5 of

the General Data Protection Regulation as it applies in the Isle of Man pursuant to the Data Protection (Application of GDPR) Order 2018, namely that Cabinet Office can only disclose the information where it would be fair, lawful and meet one of the conditions for lawful processing in Article 6 and in this case, none of those conditions have been met. The exemption has been applied to named individuals on a case-by-case basis. When deciding on whether it would be fair, lawful and meet one of the conditions in Article 6, the following factors have been considered: • Expectation of privacy for all parties • Potential harm that could be caused by disclosing that person’s name, role, grading, personal details and/or positions.

Please quote the reference number 3466333 in any future communications.

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Yours sincerely