Dear Ministry of Health,
Tēnā koutou,

More detailed information is requested on COVID-19 vaccine adverse reactions that are entered and held in CARM.

Background to Request.

Information about adverse reactions to the COVID-19 vaccine is currently included in the weekly updates about COVID-19 vaccine data issued by the Ministry of Health on its website.

These adverse reaction reports are prepared by Medsafe which is the medical regulatory body run by the New Zealand Ministry of Health, hence this request is to the Ministry of Health which is the agency responsible for the COVID-19 vaccine reporting and the content that is included in the reporting.

The COVID-19 weekly safety reports, the data for which is sourced from the CARM (Centre for Adverse Reactions Monitoring) system, currently provide high level summarized information on the numbers and types of adverse reactions to the COVID-19 vaccine with a brief description for each event type such as “1 was a seizure-type event”. The full reports, currently 1 to 7 provide similar high level information about numbers and reaction types and don’t go into any details about things like why serious reactions reported were later determined to be unrelated to the vaccine.

More detailed information on each adverse reaction is requested. This is so there is more awareness of the details surrounding adverse reactions reported and fuller information is available about the COVID-19 vaccine’s potential side effects when deciding whether to provide the formal consent that is required in order to be vaccinated for COVID-19.

This additional information may help understanding of these adverse reactions if more details about each case such as age and any details about things like underlying health conditions or the existence of accompanying serious diseases or illnesses are entered into the CARM records for cases of adverse reactions. This more detailed information may help allay any fears or reduce vaccine hesitancy in getting the COVID-19 vaccine if the details surrounding an adverse reaction are made public rather than just seeing that a stroke, for example, occurred after a vaccination. More information on why a serious reaction reported in CARM was then determined to be unrelated to the vaccine would also help in terms of providing full information prior to a vaccination.

1. Overview of Information Requested
Would you please provide all the details, excluding personal identifier information, recorded in the CARM system of each case included in the summarized reports from the CARM database published in the Medsafe COVID-19 safety reports?
Please provide the details for the COVID-19 adverse reaction cases recorded so far and for the cases entered in the CARM system going forward. Much of the information requested such as age, gender and ethnicity is already made public regarding vaccinations so a request to provide this same information for adverse reactions is in line with existing reporting on COVID-19 events. The additional information requested will provide more granular and important details about each adverse reaction. Currently only high level summarized information is provided in the weekly reports and more details about each individual case is requested. I am not requesting any personal identifier details of patients who are reporting COVID-19 vaccine side effects.
The additional information may also help understanding of why serious adverse events reported and included in these reports are not considered to be related to the vaccination.

2. Information Requested
What I am requesting for each case included in the COVID-19 vaccine safety reports issued by Medsafe to date and ongoing such as at https://www.medsafe.govt.nz/COVID-19/saf... is as follows;

For each case included in each COVID-19 vaccine safety report please report the following;
a) CARM #, the case number or unique id used in the system or some other reference number used in the system for this/each case,
b) Reporter details (member of the public, health professional, other)
c) Event narrative; the description of what happened as entered by the reporter into CARM
d) Reaction Type; for example blood clot, stroke, headache, dizziness,
e) Age; the age or age group of the person the adverse reaction report is about if known,
f) Gender; the gender of the person if known,
g) Ethnicity; the ethnicity of the person if known,
h) Date of vaccination reported in CARM if known,
i) Date adverse event reported in CARM,
j) AEFI Details (Adverse event description); the full description of the adverse event or reaction as entered in CARM by the reporter of the event,
k) Outcome; Any patient or reaction outcome recorded in the system,
l) Adverse Reaction Review; such as details as to why the adverse reaction entered into CARM was determined to be unrelated to the vaccination, as stated regarding the stroke and blood clots reported to date.
m) Other Information; Any other information pertaining to the adverse reaction entered and held in CARM not covered by the above list.
3. Please provide this information in a machine-readable spreadsheet format such as CSV or XLSX.
4. Please provide this information for the cases reported to date in the safety reports already published as at 21 May 2021, numbered 1 to 7 and any more issued at the time this request is processed.
5. Please provide this information each week for all new cases recorded in the system going forward. Please make this ongoing report available to the public via the current COVID-19 safety monitory website at https://www.medsafe.govt.nz/COVID-19/saf...
6. If any part of my request is unclear, please don't hesitate to contact me.
7. Please also explain any relevant caveats that should be kept in mind when analysing this information.
8. If any of the information that I have requested is unavailable or would be difficult to retrieve, but similar information might be readily available, I would be happy to discuss altering or refining my request.
9. I am unable to meet any costs of this request or eventual solution so please do not propose this if the cost is something you cannot account for in the government’s COVID-19 Response budget allocation. If the cost cannot be met by government funding for COVID-19, please explain what can be provided free of charge or how to refine my request in such a way that it will not result in a charge. My objective with this request is to enable full information on adverse reactions and their review to be provided especially prior to vaccine consent t this stage in the vaccine rollout so this request should be or could be defined as traceable to existing government goals and objectives for COVID-19 this year and thus be included in existing funding.
10. As a New Zealand citizen, I am eligible to make requests under the OIA.

Ngā mihi,
Geoff Curtis

Dear OIA Requests,

I have decided to withdraw this request as after further consideration I think putting a lot of raw data online without explanation or interpretation may cause confusion and end up being counter-productive in providing accurate information about the adverse reactions to the covid vaccination.

So I have withdrawn this request accordingly.

Yours sincerely,

Geoff Curtis