133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
3 October 2023
Catherine Jamieson
By email: [FYI request #23989 email]
Ref:
H2023031262
Tēnā koe Catherine
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) to Manatū Hauora
(the Ministry of Health) on 29 August 2023 for information regarding adverse events following
immunisation (AEFI). You requested:
What does the date shown in the date column when a detailed search is done in SMARS
for Covid 19 Vaccines represent?
This is the date the report was made.
What is the number shown in the report column when a detailed search is done in SMARS
for Covid 19 Vaccines? http://icmra.info/drupal/news/20july2020/summary
This is the report identification number.
For each of these report numbers please supply corresponding i)
assessment numbers (AEFI-A) numbers
ii)
assessment codes
On 6 September 2023, you were contact by Manatū Hauora to clarify what you meant by
‘assessment codes’. On 11 September 2023, you replied:
“The assessment codes I am referring to are those used in the 'Preferred Term' column of
the line listing file in the Safety Reports. My apologies for the confusion if that is not the
term commonly used to refer to them.”
These codes are the MedDRA numeric codes relating to the medical term displayed which have
never been visible in the SMARS database and were only included in the COVID-19 vaccine
downloads due to a feature of the database being used at the time. A new database is now being
bult which will still utilise MedDRA. You can find out more about MedDRA here:
https://www.meddra.org/
Please identify the reports associated with deaths of the consumer.
These are never identified in SMARS and were not identified in the COVID-19 vaccine safety
reports for privacy. This is explained in the caveat text for SMARS.
OIA response H2023021744 identifies a significant difference between the serious adverse
event reports received and those publicly reported through Medsafe Safety Reports and
SMARS. Please supply any reports, emails or other correspondence pertaining to the
difference between reports of adverse events following immunisation with Covid vaccines
received and those reported in Medsafe Safety Report #46.
The difference was due to the COVID-19 vaccine reports not being fully integrated into the
normal CARM database. Since the databases have not yet been joined a line listing for COVID-
19 vaccine reports was publishe
d www.medsafe.govt.nz/safety/reports-and-promotion/ADR-
reporting-statistics.asp
How many adverse event reports following immunisation have been received to date for
Covid vaccines, both total reports and those that fall under the Medsafe definition of
Serious.
Data reported to the Centre for Adverse Reactions Monitoring is published here:
www.medsafe.govt.nz/safety/reports-and-promotion/ADRStatistics/Comirnaty2023.asp.
Please also supply any reports, emails or other correspondence pertaining to any
discussion, since the issue of Medsafe Safety Report #46, of safety signals.
On 6 September 2023, you were contacted by Manatū Hauora in accordance with section 18B of
the Act in order to refine this part of your request. This part of your request captured all Medsafe
correspondence following the Safety Report #46. On 11 September 2023, you provided a refined
request for:
'Post safety report 46 to present day, please provide all meeting minutes detailing any new
safety signals related to Covid 19 vaccines, also email and memorandum issued post 16
December 2022 in respect to those safety signals.'
There have been no new safety signals since the publication of Safety Report #46. Therefore,
this part of your request is refused under section 18(g)(i) of the Act as the information is not held
by Manatū Hauora and there are no grounds for believing it is held by any other agency subject
to the Act.
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.
Please note that this response, with your personal details removed, may be published on the
Manatū Hauora website at:
www.health.govt.nz/about-ministry/information-releases/responses-
official-information-act-requests. Nāku noa, nā
Chris James
Group Manager
Medsafe
Page 2 of 2
