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COVID-19 vaccines: Safety Report Statistics

Paul Jones made this Official Information request to Ministry of Health

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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

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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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References

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1. file:///s:/www.medsafe.govt.nz/COVID-19/vaccine-report-over

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