2139942 Covid vaccine adverse events

Summary

The requester asked Manx Care about data collection on COVID-19 vaccine adverse events, staff awareness of side effects, and public reporting mechanisms. Manx Care disclosed that they rely on UK MHRA data, provide staff with updated Patient Group Directions and the Green Book, and clarified that 111 does not handle vaccination consent.

Key Facts

• Manx Care requests breakdowns of adverse drug reactions from the UK MHRA but cannot obtain specific details on individual cases.
• Medical staff are informed of side effects through manufacturer leaflets, Patient Group Directions (PGDs), and the Green Book Chapter 14a.
• The 111 service does not gain consent for vaccination and therefore does not provide updates on adverse events for that purpose.
• Healthcare professionals must read and sign PGDs or PSDs before administering vaccines.
• Information on adverse events is considered an indication of possible reactions rather than medically verified clinical data.

Data Disclosed

• 882 adverse events
• 5th November 2021
• 10 December 2021
• 1 February 2022
• Chapter 14a

Original Request

1. Is Isle of Man collecting data on covid vaccine injury for themselves, or requesting it from the UK MHRA? 2. Are GP's, medical teams and 111 being informed of the 882 adverse events reported to the yellowcard system up to 5th November 2021 by manxcare or anyone? Are they being given regular updates to properly inform people before gaining consent for vaccination? 2. Have the hospital medical staff and doctors, GP's been given a list of covid vaccine side effects to look out for? If yes, please could I see a copy of such a list. Has this list changed? If no list, how is the medical team being informed of the signs to look out for, to ensure covid vaccine injuries are captured and reported, and patients given correct diagnosis. 3. Is there a requirement for doctors & medical staff to report vaccine injuries onto the yellowcard system, and have all doctors/medical staff been made aware of this? 4. There are many people who do not know about the yellowcard reporting system for adverse events and therefore are not reporting it. Does the 111 team have a duty to inform people of the yellowcard system? Who is responsible for making people aware this reporting site exists? And how is manxcare informing the public of this reporting system, during the use of a trial vaccine on the manx community.

Data Tables (1)

Full Response Text

Manx Care Noble’s Hospital, Strang Braddan, Isle of Man IM4 4R (01624) 650 000

Our ref: 2139942 1 February 2022

Dear ###

We write further to your request which was received on 10 December 2021 and which states:

"1. Is Isle of Man collecting data on Covid vaccine injury for themselves, or requesting it from the UK MHRA? 2. Are GP's, medical teams and 111 being informed of the 882 adverse events reported to the yellow card system up to 5th November 2021 by Manx Care or anyone? Are they being given regular updates to properly inform people before gaining consent for vaccination? 3. Have the hospital medical staff and doctors, GP's been given a list of Covid vaccine side effects to look out for? If yes, please could I see a copy of such a list? Has this list changed? If no list, how is the medical team being informed of the signs to look out for, to ensure Covid vaccine injuries are captured and reported, and patients given correct diagnosis? 4. Is there a requirement for doctors & medical staff to report vaccine injuries onto the yellow card system, and have all doctors/medical staff been made aware of this? 5. There are many people who do not know about the yellow card reporting system for adverse events and therefore are not reporting it. Does the 111 team have a duty to inform people of the yellow card system? Who is responsible for making people aware this reporting site exists? And how is Manx Care informing the public of this reporting system, during the use of a trial vaccine on the Manx community."

Our response: Q1. Is Isle of Man collecting data on Covid vaccine injury for themselves, or requesting it from the UK MHRA? All information is publically available from the MHRA, please see link: https://www.gov.uk/government/collections/mhra-guidance-on-coronavirus-covid-19 Manx Care request a breakdown of the specific adverse drug reactions (ADR’s) regularly, this is provided to the Department of Health and Social Care and Manx Care, but Manx Care are unable to obtain specific information about each ADR only that provided by the MHRA (Vaccine type and general information on the ADR type itself).

Q2. Are GP's, medical teams and 111 being informed of the 882 adverse events reported to the yellow card system up to 5th November 2021 by Manx Care or anyone? Are they being given regular updates to properly inform people before gaining consent for vaccination? Teams who facilitate vaccinations are provided with the relevant information, which is produced by the MHRA and the manufacturer within the relevant documentation. The information provided to the MHRA is not medically verified and as such is only an indication of possible adverse reactions, as such this is not a clinical document. 111 do not gain consent for vaccination when they have contact with the public. Q3. Have the hospital medical staff and doctors, GP's been given a list of covid vaccine side effects to look out for? If yes, please could I see a copy of such a list. Has this list changed? If no list, how is the medical team being informed of the signs to look out for, to ensure covid vaccine injuries are captured and reported, and patients given correct diagnosis. The specific side effects are contained within the information leaflets provided with each of the vaccines. This information is updated regularly as part of the vaccines authorisation. Revised information is promulgated as information for healthcare professionals, but also within the Patient Information Leaflets. All persons completing vaccinations are required to read and sign a Patient Group Direction (PGD) for each vaccine they administer, prior to vaccination or in the case of GP’s (where applicable) they are required to complete a PSD. These various documents are updated by the manufacturer, by the MHRA from time to time and are updated on the website. PGD’s are re-issued and updated on a regular basis and provide relevant information (the current Comirnaty PGD is attached for information). Additionally the Green Book (which is attached for information), Chapter 14a provides significant information in regards to the vaccines and the potential reactions, all healthcare professionals should read and understand this document, again this document is updated on a regular basis. Q4. Is there a requirement for doctors & medical staff to report vaccine injuries onto the yellow card system, and have all doctors/medical staff been made aware of this? Yes there is a requirement, where there is a causal link between a symptom and a vaccine. Vaccination staff are aware of this requirement. Q5. There are many people who do not know about the yellow card reporting system for adverse events and therefore are not reporting it. Does the 111 team have a duty to inform people of the yellow card system? Who is responsible for making people aware this reporting site exists? And how is Manx Care informing the public of this reporting system, during the use of a trial vaccine on the Manx community."

111 do not have a ‘duty’ to inform people of the yellow card system, 111 can (and do) signpost people to the Isle of Man Government’s Covid 19 website (https://covid19.gov.im/vaccination/vaccine-side-effects-and-safety/) where there is information on side effects and a link to a reporting mechanism. Manx Care inform the public by: https://covid19.gov.im/vaccination/vaccine-side- effects-and-safety/, on invitation letters for vaccinations, on each of the consent forms that each person consenting to a vaccination must complete and state that they have read and understood the documents including the Patient Information Leaflets (and therefore the reporting options). Please quote the reference number 2139942 in any future communications.

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I will now close your request as of this date.

Yours faithfully