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