Covid Vaccine Adverse Event Following Immunisation Reporting
Catherine Jamieson made this Official Information request to Ministry of Health
The request was partially successful.
From: Catherine Jamieson
Dear Ministry of Health,
This is a request for information pursuant to the Official Information Act.
What does the date shown in the date column when a detailed search is done in SMARS for Covid 19 Vaccines represent?
What is the number shown in the report column when a detailed search is done in SMARS for Covid 19 Vaccines?
For each of these report numbers please supply corresponding
i) assessment numbers (AEFI-A) numbers
ii) assessment codes
Please identify the reports associated with deaths of the consumer.
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.
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.
Please also supply any reports, emails or other correspondence pertaining to any discussion, since the issue of Medsafe Safety Report #46, of safety signals.
Yours faithfully,
Catherine Jamieson
From: OIA Requests
Kia ora Catherine
Thank you for your request for official information. The reference number
for your request is: H2023031262
As required under the Official Information Act 1982, Manatū Hauora will
endeavour to respond to your request no later than 20 working days after
the day your request was received. If you'd like to calculate the
timeframe, you can use the Ombudsman's online calculator
here: [1]http://www.ombudsman.parliament.nz/
If you have any queries, please feel free to contact the OIA Services Team
on [2][email address]. If any additional factors come to light which
are relevant to your request, please do not hesitate to contact us so that
these can be taken into account.
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: [3][email address] or by calling 0800
802 602.
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[4]inistry of Health information releases
U[5]nite against COVID-19
show quoted sections
From: OIA Requests
Kia ora Catherine,
Thank you for your request for official information, received on 29 August
2023 for information regarding adverse events following immunisation
(AEFI) and SMARS data.
We are contacting you in accordance with section 18B of the Official
Information Act 1982 (the Act) as your part of your request, as it is
currently worded, requires a search through a very large volume of
information. Specifically, your request for:
“Please also supply any reports, emails or other correspondence pertaining
to any discussion, since the issue of Medsafe Safety Report #46, of safety
signals”.
This part of your request may be refused under section 18(f) of the Act as
the information requested cannot be made available without substantial
collation or research. If you are able to refine the scope of your request
by selecting a shorter time frame, specifying a topic and/ or limiting the
type of documents you are requesting, we may be able to provide you with
information you are interested in.
We are also contacting you to clarify what you mean by assessment codes as
quoted in your original request.
Please respond by 12 September 2023 so that we can consider
your refinement and clarification in our response to your request.
Please note, under section 15 of the Official Information Act 1982, any
clarification or amendments made to a request within seven days after the
date it is received, that request may be treated as a new request and the
time limit for the response restarts.
We look forward to receiving your response.
Ngâ mihi
OIA Services Team
Manatû Hauora | Ministry of Health
M[1]inistry of Health information releases
U[2]nite against COVID-19
show quoted sections
References
Visible links
1. https://www.health.govt.nz/about-ministr...
2. https://covid19.govt.nz/
From: OIA Requests
Kia ora Catherine,
Thank you for your request for official information, received on 29 August
2023 for information regarding adverse events following immunisation
(AEFI) and SMARS data.
We are contacting you in accordance with section 18B of the Official
Information Act 1982 (the Act) as your part of your request, as it is
currently worded, requires a search through a very large volume of
information. Specifically, your request for:
“Please also supply any reports, emails or other correspondence pertaining
to any discussion, since the issue of Medsafe Safety Report #46, of safety
signals”.
This part of your request may be refused under section 18(f) of the Act as
the information requested cannot be made available without substantial
collation or research. If you are able to refine the scope of your request
by selecting a shorter time frame, specifying a topic and/ or limiting the
type of documents you are requesting, we may be able to provide you with
information you are interested in.
We are also contacting you to clarify what you mean by assessment codes as
quoted in your original request.
Please respond by 12 September 2023 so that we can consider
your refinement and clarification in our response to your request.
Please note, under section 15 of the Official Information Act 1982, any
clarification or amendments made to a request within seven days after the
date it is received, that request may be treated as a new request and the
time limit for the response restarts.
We look forward to receiving your response.
Ngâ mihi
OIA Services Team
Manatû Hauora | Ministry of Health
M[1]inistry of Health information releases
U[2]nite against COVID-19
show quoted sections
References
Visible links
1. https://www.health.govt.nz/about-ministr...
2. https://covid19.govt.nz/
From: Catherine Jamieson
Dear OIA Requests,
Thank you for your 7 September 2023 correspondence.
I have chosen to refine my request by limiting to only new safety signals in respect of Covid vaccines since the issue of Safety Report 46 in mid December 2022. The request is now:-
'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.'
I trust that information can be made available with substantial collation and research.
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.
Yours sincerely,
Catherine Jamieson
From: Catherine Jamieson
Dear OIA Requests,
Could you please provide an update as to when this information will be made available?
Yours sincerely,
Catherine Jamieson
From: OIA Requests
Kia ora Catherine
Please find attached a letter regarding your request for information
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[1]inistry of Health information releases
U[2]nite against COVID-19
show quoted sections
References
Visible links
1. https://www.health.govt.nz/about-ministr...
2. https://covid19.govt.nz/
From: Catherine Jamieson
Dear OIA Requests,
Outlined below are questions still outstanding subsequent to Mr James' 3 October 2023 reply.
1. 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.
2. 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?
Please do not apply another 20 working day timeframe as these are the same questions from the original 29 August request reiterated as they were not answered. Notes below.
1. This answer goes nowhere near being able to explain the difference between the 3688 serious reports named in Safety Report 46 and the number identified in H2023021744. If there are reports, emails or other correspondence pertaining to this difference they should be provided please. If no material pertaining to this anomaly exists please specify that is the case.
2. I requested a number for both total adverse event reports and those that fall under the Medsafe definition of serious for Covid vaccines. The link I have been referred to informs that reports for the bivalent are excluded as are any report where death is the only reported reaction. In addition there is no way to differentiate serious reports.
Yours faithfully,
Catherine Jamieson
From: OIA Requests
Kia ora Catherine,
Please find attached a response to your request for official information.
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[1]inistry of Health information releases
U[2]nite against COVID-19
show quoted sections
References
Visible links
1. https://www.health.govt.nz/about-ministr...
2. https://covid19.govt.nz/
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Athina Andonatou left an annotation ()
Also interested in the reply. Thank you Catherine for your tenacity
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