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Vaccine Adverse Reaction Reporting Standards

Mr M Bell made this Official Information request to Ministry of Health

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From: Mr M Bell

Dear Ministry of Health,

Kia Ora

1. Is there a standard by which vaccine adverse reactions are qualified? i.e how does the agency recording adverse reactions qualify that the reaction was caused by a vaccine, does medsafe or other government agencies have guidelines about this? Put another way how is an adverse reaction classified as being caused by a vaccine?

Yours faithfully,

Mr M Bell

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From: OIA Requests


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Kia ora M Bell

 

 

Thank you for your correspondence received on 9 April 2021.

 

Adverse events following immunisation (AEFI) for the COVID-19 vaccine are
reported to the Centre for Adverse Reactions Monitoring (CARM). Any side
effects reported are suspected by the reporter to be caused by the
vaccine. It doesn’t always mean the vaccine did cause the side effect. You
may wish to refer to the New Zealand Pharmacovigilance Centre for further
information: [1]https://nzphvc.otago.ac.nz/reporting/.

 

Medsafe closely monitors and releases a safety report showing this data
each week. This shows the most common side effects that people in New
Zealand experience after getting the COVID-19 vaccine:
[2]https://www.health.govt.nz/our-work/dise...

 

I trust this information fulfils your request.  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.

 

 

Ngâ mihi

 

OIA Services Team

 

[3]Ministry of Health information releases

[4]Unite against COVID-19

 

 

  

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From: Mr M Bell <[5][FOI #15119 email]>
Sent: Friday, 9 April 2021 16:10
To: OIA Requests <[6][email address]>
Subject: Official Information request - Vaccine Adverse Reaction Reporting
Standards

 

Dear Ministry of Health,

Kia Ora

1. Is there a standard by which vaccine adverse reactions are qualified? 
i.e how does the agency recording adverse reactions qualify that the
reaction was caused by a vaccine, does medsafe or other government
agencies have guidelines about this?  Put another way how is an adverse
reaction classified as being caused by a vaccine?

Yours faithfully,

Mr M Bell

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References

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1. https://nzphvc.otago.ac.nz/reporting/
2. https://www.health.govt.nz/our-work/dise...
3. https://www.health.govt.nz/about-ministr...
4. https://covid19.govt.nz/
5. mailto:[FOI #15119 email]
6. mailto:[email address]
7. mailto:[FOI #15119 email]
8. mailto:[Ministry of Health request email]
9. https://scanmail.trustwave.com/?c=15517&...
10. https://scanmail.trustwave.com/?c=15517&...

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From: Mr M Bell

Dear OIA Requests,

That does not answer my request.

When CARM receives a report, how do they determine if a report is valid i.e caused by a vaccine or not, who decides and by what standard do they make that decision.

Yours sincerely,

Mr M Bell

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