Deaths and Miscarriage adverse reactions following Covid-19 vaccination
Mary Devlin made this Official Information request to Ministry of Health
The request was successful.
From: Mary Devlin
Dear Ministry of Health,
Information about adverse reactions to the COVID-19 vaccine is currently included in the weekly updates about COVID-19 vaccine data issued by the Ministry of Health on its website.
My request is to the Ministry of Health which is responsible for the COVID-19 vaccine reporting and the content that is included in the reporting.
Medsafe currently includes an AEFI (Adverse Events Following Immunisation) spreadsheet with each weekly safety report that provides information about each adverse reaction reported including summarizing the narrative entered into CARM into a preferred term for the reaction. Information for these reports is sourced from The Centre for Adverse Reactions Monitoring (CARM) in Dunedin which is the national repository for adverse reaction reports.
My questions are in relation to this weekly spreadsheet.
Up to and including 19 June 2021, a total of 16 deaths were reported to CARM after the administration of the Pfizer Comirnaty vaccine.
I am unable to find any reference to these 16 deaths in the spreadsheet included with the safety reports up to and including 19 June.
Also, the Ministry of Health recently announced that pregnant people will now be routinely offered the Pfizer mRNA vaccine at any stage of pregnancy. Data from at least one study shows a concerning rate of spontaneous abortions (miscarriages) for women vaccinated in the first 20 weeks of their pregnancy. Concerning numbers of miscarriages have also been reported in Vaccine Adverse Event Reaction systems such as the UK Yellow Card system and the United States VAERS system.
So my questions are as follows;
1. The weekly spreadsheet is a listing of AEFIs (Adverse Events Following Immunization) received from responders. As stated, an AEFI is considered serious if it results in a death. Where and how are these 16 deaths, each of which is considered to be a serious AEFI, represented in the most recent weekly AEFI spreadsheet?
a. Which line numbers in the AEFI spreadsheet correspond to the deaths reported?
2. Could you please add a date of death field to the AEFI spreadsheet to indicate that a death reaction has occurred?
3. How are miscarriages or spontaneous abortions as they are medically referred to, to be represented in the weekly AEFI spreadsheet published going forward?
4. How have miscarriages or spontaneous abortions as they are medically referred to been represented in the weekly AEFI spreadsheet to date?
5. The latest AEFI spreadsheet as at this date includes an abortion following abdominal pain. Is this a miscarriage or spontaneous abortion? Please clarify this entry?
6. The latest AEFI spreadsheet as of 19 June includes 274 reports of abdominal pain, 146 of these were for women under 50 years of age. Did any of these women also suffer a spontaneous abortion or miscarriage?
7. How many reports that include a miscarriage, abortion, spontaneous abortions, or otherwise refer to the loss of an unborn baby have been entered into CARM in relation to a person receiving the COVID-19 vaccine?
8. In the weekly AEFI spreadsheet going forward please include all reports of a miscarriage, abortion, spontaneous abortions, or otherwise refer to the loss of an unborn baby and identify them accordingly, where they are or have been entered into CARM in relation to a person receiving the COVID-19 vaccine?
Thank you so much.
Yours faithfully,
Mary Devlin
From: OIA Requests
Kia ora Mary,
Thank you for your request for official information received on 14 July
2021 for:
"1.The weekly spreadsheet is a listing of AEFIs (Adverse Events Following
Immunization) received from responders. As stated, an AEFI is considered
serious if it results in a death.
Where and how are these 16 deaths, each of which is considered to be a
serious AEFI, represented in the most recent weekly AEFI spreadsheet?
a. Which line numbers in the AEFI spreadsheet correspond to the deaths
reported?
2. Could you please add a date of death field to the AEFI spreadsheet to
indicate that a death reaction has occurred?
3. How are miscarriages or spontaneous abortions as they are medically
referred to, to be represented in the weekly AEFI spreadsheet published
going forward?
4. How have miscarriages or spontaneous abortions as they are medically
referred to been represented in the weekly AEFI spreadsheet to date?
5. The latest AEFI spreadsheet as at this date includes an abortion
following abdominal pain. Is this a miscarriage or spontaneous abortion?
Please clarify this entry?
6. The latest AEFI spreadsheet as of 19 June includes 274 reports of
abdominal pain, 146 of these were for women under 50 years of age. Did any
of these women also suffer a spontaneous abortion or miscarriage?
7. How many reports that include a miscarriage, abortion, spontaneous
abortions, or otherwise refer to the loss of an unborn baby have been
entered into CARM in relation to a person receiving the COVID-19 vaccine?
8. In the weekly AEFI spreadsheet going forward please include all reports
of a miscarriage, abortion, spontaneous abortions, or otherwise refer to
the loss of an unborn baby and identify them accordingly,
where they are or have been entered into CARM in relation to a person
receiving the COVID-19 vaccine?"
The Ministry's reference number for your request is: H202108555.
As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 11 August 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: [1][email address]
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From: OIA Requests
Kia ora Mary,
Please find attached a response to your official information act request.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [1][email address]
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Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
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