133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
14 December 2021
Tess McCawe
By email: [FYI request #17452 email]
Ref:
H202116818
Dear Tess
Response to your request for official information
Thank you for your follow up request under the Official Information Act 1982 (the Act) to the
Ministry of Health (the Ministry) on 25 November 2021. You specifically requested:
“I have not been provided with the information I requested. I asked specifically for the
decision making criteria for how MoH changed the information related to the reaction I had
to the vaccine which was reported by a health professional who was there as “medically
significant “ and “serious”. MoH have changed my record to other categories which were
not experienced by me. MoH created a new form with a new number and new information
and not provided it. As I lay on the chemist floor, the defibrillator was out and ambulance
called because of my heart symptoms. MoH has denied that this happened. The “significant
and prolonged shaking” was described as very uncommon but MoH have said it is
common. MoH have not provided me with the information requested which is the criteria
and process they used to change my medical records.
As MoH’s false records wil be used to deny me an exemption, I want to know how they
explain changing my records.”
Copies of the responses to your previous requests, reference numbers H202114758 and
H202115491, are enclosed as Appendix 1 and 2.
The adverse event following immunisation (AEFI) report attached as Appendix 3 confirms the
details of the report made to the Centre for Adverse Reactions Monitoring (CARM) regarding your
adverse event following COVID-19 vaccination. This information was sourced from the COVID-
CARM database on 26 November 2021. As you have declined to provide an email address, the
Ministry has withheld information that may identify you under section 9(2)(a) of the Act, to protect
the privacy of natural persons.
You have the right to ask the Ministry to amend any incorrect information it holds about you.
Please contact the Ministry via email at
[email address] if you believe any
personal information in this report requires correction or if you have any further inquiry regarding
information held about you in the COVID-CARM database.
CARM completes a medical assessment of each report to identify and classify reactions for
reporting purposes. Information on how CARM assesses these reports is available at:
•
www.vaccine-safety-training.org/causality-assessment-of-aefis.html
•
www.who.int/publications/i/item/causality-assessment-aefi-user-manual-2019
•
https://apps.who.int/iris/handle/10665/338400
As explained in the previous response (ref: H202115391), if an event is not classified as an
adverse event of special interest (AESI), this does not mean that it is not medically significant. An
event may be medically significant without being classified as an AESI. As per your AEFI report
attached as Appendix 3, the events you experienced were considered medically significant.
The information included in the attached report is what is taken into account by your healthcare
professional when you apply for an exemption. The CARM medical assessment of the event has
no relevance and is not part of the exemption process, and an event does not have to be
classified as an AESI in order to qualify for an exemption.
Under section 28(3) of the Act, you have the right to ask the Ombudsman to review any
decisions made under this request. The Ombudsman may be contacted by email at:
[email address] or by calling 0800 802 602.
Yours sincerely
Chris James
Group Manager
Medsafe
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