COVID-19 vaccines: Safety Report Statistics
Paul Jones made this Official Information request to Ministry of Health
The request was successful.
From: Paul Jones
Dear Ministry of Health,
Concerning the Weekly Safety Reports on Medsafe for Covid 19 vaccine adverse events here https://www.medsafe.govt.nz/COVID-19/vac...
With respect to Report #9 we comment;
Our complaint is Medsafe is not providing full disclosure of the summarised data on the weekly safety reports as other governments provide (eg: UK's Yellow Card Report).
Medsafe have chosen to censor the serious reports by only providing the Top 10 most frequent AEFI's which out number the serious reports and are not disclosed in the table with there numerical count.
In the written language it lists some of the serious reports, eg: "The remaining serious reports were for: transient ischemic attack (stroke-like symptoms), stroke, seizure, Bell’s Palsy, hearing loss, hyperglycaemia, impaired consciousness and spontaneous bleeding from the groin.", but this does not provide a numerical count as 8 side effects are written to cover 13 serious reports.
Our request is for full disclosure and for the AEFI table to list ALL mild and serious events and there numerical count and to cease only providing the Top 10 reactions.
Secondly we request for the AEFI table to provide two numerical values, i) the number of new reported cases for the week, ii) the cummulative number of reports since beginning of CARM data recording.
Yours faithfully,
Paul Jones
From: OIA Requests
Kia ora
Thank you for your request for official information received on 4 June
2021 for:
"Concerning the Weekly Safety Reports on Medsafe for Covid 19 vaccine
adverse events here
http[1]s://www.medsafe.govt.nz/COVID-19/vaccine-report-overview.asp
With respect to Report #9 we comment;
Our complaint is Medsafe is not providing full disclosure of the
summarised data on the weekly safety reports as other governments provide
(eg: UK's Yellow Card Report).
Medsafe have chosen to censor the serious reports by only providing the
Top 10 most frequent AEFI's which out number the serious reports and are
not disclosed in the table with there numerical count.
In the written language it lists some of the serious reports, eg: "The
remaining serious reports were for: transient ischemic attack (stroke-like
symptoms), stroke, seizure, Bell’s Palsy, hearing loss, hyperglycaemia,
impaired consciousness and spontaneous bleeding from the groin.", but this
does not provide a numerical count as 8 side effects are written to cover
13 serious reports.
Our request is for full disclosure and for the AEFI table to list ALL mild
and serious events and there numerical count and to cease only providing
the Top 10 reactions.
Secondly we request for the AEFI table to provide two numerical values, i)
the number of new reported cases for the week, ii) the cummulative number
of reports since beginning of CARM data recording."
The Ministry's reference number for your request is: H202106858.
As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 5 July 2021, being 20
working days after the day your request was received.
If we are unable to respond to your request within this time frame, we
will notify you of an extension of that time frame.
If you have any queries related to this request, please do not hesitate to
get in touch.
Ngâ mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
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1. file:///s:/www.medsafe.govt.nz/COVID-19/vaccine-report-over
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From: OIA Requests
Kia ora Paul
Please find attached a letter regarding your request for official
information.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
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From: Paul Jones
Dear OIA Requests,
Thank you for your reply, would you please confirm if Safety Report 14 that you mention has actually made the changes requested or should we be expecting them from Report number 15 onwards?
From our review Report 14 does NOT contain the changes as it;
1) still lists the "Top 10" reactions in the AEFI tables,
2) does not provide a numerical count of the serious reactions for the week as the report lists 23 serious events and only describes 21 of them as;
Furthermore, five of the serious reports were described as allergic reactions and the remaining reports were for: stroke (3), atrial fibrillation (2), seizure (2), c-reactive protein increased (2), deep vein thrombosis (DVT), hypotension, myopericarditis, ataxia, Guillain-Barré syndrome, blood in urine (haematuria) and jaundice.
Please promptly confirm?
Yours sincerely,
Paul Jones
From: Paul Jones
Dear OIA Requests,
To correct my previous response at (2), the missing 2 serious events are the death events to bring the total up to 23.
My issue with (1) still stands with only showing the Top 10 events. The AEFI Table data should list all events without discrimination.
Yours sincerely,
Paul Jones
From: OIA Requests
Kia ora Paul
At the bottom of the page is a link to the list of the full reports.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
-----Original Message-----
From: Paul Jones <[FOI #15670 email]>
Sent: Thursday, 1 July 2021 5:54 pm
To: OIA Requests <[email address]>
Subject: Re: Response to your request for official information (H202106858)
Dear OIA Requests,
Thank you for your reply, would you please confirm if Safety Report 14 that you mention has actually made the changes requested or should we be expecting them from Report number 15 onwards?
From our review Report 14 does NOT contain the changes as it;
1) still lists the "Top 10" reactions in the AEFI tables,
2) does not provide a numerical count of the serious reactions for the week as the report lists 23 serious events and only describes 21 of them as;
Furthermore, five of the serious reports were described as allergic reactions and the remaining reports were for: stroke (3), atrial fibrillation (2), seizure (2), c-reactive protein increased (2), deep vein thrombosis (DVT), hypotension, myopericarditis, ataxia, Guillain-Barré syndrome, blood in urine (haematuria) and jaundice.
Please promptly confirm?
Yours sincerely,
Paul Jones
-----Original Message-----
Kia ora Paul
Please find attached a letter regarding your request for official information.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
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Paul Jones left an annotation ()
Note the full information of all adverse events is now provided as a XLSM file at the bottom of the safety report.
1) Goto https://www.medsafe.govt.nz/COVID-19/saf...
2) Scroll down to the bottom of the page and at the very bottom is has the link and text;
The latest listing of AEFIs received is included in the attached spreadsheet. Medsafe advises patients NOT to make any decisions about vaccination based on information contained here.
Download AEFI-line-listing.xlsm
From: Paul Jones
Dear OIA Requests,
Thank you for the XLSM data file at https://www.medsafe.govt.nz/COVID-19/AEF... containing the adverse events.
Naturally I have the following requests to the XLSM file;
1) Column "Date first reported" contains the Month and Year of the AEFI event. We appreciate you are trying to anonymize the data, however as the Safety reports are issued weekly, we request for this column to show what "Week" of the year it was filed instead of the Month, eg: "Week 23,21" to indicate Week 23 of 2021.
2) Safety Report #14 lists a total of 4521 Total AEFI reports that were received (cumulative). In the XLSM file a total of 4511 events has been provided, ie: there are 10 missing events. We suspect 8 of those missing events are the death reports as we can not find those.
(i) Would you provide the "Preferred Term" number (the code in the parentheses) used for reporting the 8 deaths.
(ii) Confirm what events have been excluded when generating the XLSM file that may explain the 10 missing events.
3) We request a column to be added for Ethnicity as are given in the written reports.
4) Does the CARM system record the date the injection/administration of the dose was made? If so then would you provide a further Column containing the number of days since dose administration until report filing date for each AEFI event.
Yours sincerely,
Paul Jones
Paul Jones left an annotation ()
I suspect the other 2 missing events are the Infant events excluded in Safety Report #10, as it states in Report #14;
The total is different from the cumulative total above because it excludes 2 AEFI reports received for infants who did not receive the vaccine (see safety report 10).
Virginia Crawford left an annotation ()
The links provided are to an excel file, but it contains NO DATA, only a blurb saying that not too much reliance should be placed on it.
Virginia Crawford left an annotation ()
Sorry, cancel my last note - the data IS there, it's just that the "Read First" tab wasn't filled out in the original file I downloaded.
From: OIA Requests
Kia ora Paul,
Thank you for your request for official information received on 2 July
2021 for:
"Naturally I have the following requests to the XLSM file;
1) Column "Date first reported" contains the Month and Year of the AEFI
event. We appreciate you are trying to anonymize the data, however as the
Safety reports are issued weekly, we request for this column to show what
"Week" of the year it was filed instead of the Month, eg: "Week 23,21" to
indicate Week 23 of 2021.
2) Safety Report #14 lists a total of 4521 Total AEFI reports that were
received (cumulative). In the XLSM file a total of 4511 events has been
provided, ie: there are 10 missing events. We suspect 8 of those missing
events are the death reports as we can not find those.
(i) Would you provide the "Preferred Term" number (the code in the
parentheses) used for reporting the 8 deaths.
(ii) Confirm what events have been excluded when generating the XLSM file
that may explain the 10 missing events.
3) We request a column to be added for Ethnicity as are given in the
written reports.
4) Does the CARM system record the date the injection/administration of
the dose was made? If so then would you provide a further Column
containing the number of days since dose administration until report
filing date for each AEFI event."
The Ministry's reference number for your request is: H202108046.
As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 30 Jul 2021, being 20
working days after the day your request was received.
If we are unable to respond to your request within this time frame, we
will notify you of an extension of that time frame.
If you have any queries related to this request, please do not hesitate to
get in touch.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
-----Original Message-----
From: Paul Jones <[FOI #15670 email]>
Sent: Friday, 2 July 2021 4:08 pm
To: OIA Requests <[email address]>
Subject: RE: Response to your request for official information
(H202106858)
Dear OIA Requests,
Thank you for the XLSM data file at
[1]https://www.medsafe.govt.nz/COVID-19/AEF... containing
the adverse events.
Naturally I have the following requests to the XLSM file;
1) Column "Date first reported" contains the Month and Year of the AEFI
event. We appreciate you are trying to anonymize the data, however as the
Safety reports are issued weekly, we request for this column to show what
"Week" of the year it was filed instead of the Month, eg: "Week 23,21" to
indicate Week 23 of 2021.
2) Safety Report #14 lists a total of 4521 Total AEFI reports that were
received (cumulative). In the XLSM file a total of 4511 events has been
provided, ie: there are 10 missing events. We suspect 8 of those missing
events are the death reports as we can not find those.
(i) Would you provide the "Preferred Term" number (the code in the
parentheses) used for reporting the 8 deaths.
(ii) Confirm what events have been excluded when generating the XLSM file
that may explain the 10 missing events.
3) We request a column to be added for Ethnicity as are given in the
written reports.
4) Does the CARM system record the date the injection/administration of
the dose was made? If so then would you provide a further Column
containing the number of days since dose administration until report
filing date for each AEFI event.
Yours sincerely,
Paul Jones
-----Original Message-----
Kia ora Paul
At the bottom of the page is a link to the list of the full reports.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[2][FOI #15670 email]
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[3]https://scanmail.trustwave.com/?c=15517&...
If you find this service useful as an Official Information officer, please
ask your web manager to link to us from your organisation's OIA or LGOIMA
page.
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References
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1. https://www.medsafe.govt.nz/COVID-19/AEF...
2. mailto:[FOI #15670 email]
3. https://scanmail.trustwave.com/?c=15517&...
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victor left an annotation ()
Keep the pressure on.
Improvements in data availability are happening thanks to these such OIA requests and the efforts around them.
MOH MEDSAFE should not need to be OIA'd to provide data of this type
But it is the standard practice not to and then dodge. As chris james stated in the two elderly deaths
'They had comorbidity's and it was decided that's why they're now dead. Not the mrna injection they had recently received. (Paraphrase)
Every named individual and group involved in the severe AE assessments including death MUST be named and identified so the decision process can be validated and verified.
Trust us. Isn't acceptable.
victor left an annotation ()
8 entries in the xlsm file.
Age Group: 0 - 9
Female: 7
Male: 1
Why are these aged babies infants children being injected with pfizer comirnaty?
From: OIA Requests
Kia ora Paul,
Please find attached the response for your request for official
information.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [1][email address]
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Paul Jones left an annotation ()
We now have a listing of the data in CSV form so this OIA request is now complete.
We note that not ALL data fields will be provided due to Medsafes interpretation of protecting patient privacy.
Unlike the USA's VAERS system which provides many more details, Medsafe has chosen to be cautious so to be fair if we want the further fields then a request would need to be made to the Ombudsman for an independent evaluation and determination of the level of detail that can be provided to the public.
victor left an annotation ()
Very good pressure Paul. The focus on this is important as the analysis needs to be done and it wont be by any official channel.
There appears to be some serious weakness and lack of details on the deaths summary page through the language and working on the page there is a number of OIAs which could be raised.
I'm not able to raise them are you open to hearing the thinking?
Thanks for the efforts.
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victor left an annotation ()
Hi Paul.
The reports are an ambiguous mash of alphanumerical interchanging language and medical terminologies.
All points you raise are exactly why MEDSAFE and MOH must publish xls, csv document format with every comirnaty adverse entry listed with names removed.
Hiding behind personal privacy as reason provided for not sharing such a file is as untenable as it is the historical standard practice in restricting access as tightly as possible.
Csv document IS published to show progress of the rollout so clearly there is bias.
The written adverse event stats do not match the picture with a delta of 2 serius adverse events.
The file must be published and there is a number of precedents for CARM adverse event release under OIA with regards to injectable products which are part of the routine national schedule.
Link to this