Reporting adverse reactions to Covid-19 vaccines in New Zealand

A vaccination programme using the Pfizer/BioNtech mRNA Covid-19 vaccine “COMIRNATY” began in New Zealand on February 20, 2021 with border workers [1] and health professionals who work in South Auckland [2] being the first to be offered a jab.

If mainstream media were your only source of information on the vaccine, it would seem to be the safest shot in the world.  Indeed, on February 18, the NZ Herald actually ran a story with the title:  “Covid 19 coronavirus: Why new vaccine is safe – your questions answered”. [3]

If you read the datasheet for the vaccine, you could well be left with the rosy impression that the vaccine is safe and the only side effects you have to worry about are anaphylaxis and temporary facial palsy – and that both of these are rare.  (A comprehensive analysis of the shortcomings of the datasheet for “COMIRNATY” and information about the potential risks of the vaccine that are omitted from the datasheet may be read at this link: https://therealnews.nz/2021/02/14/does-the-nz-datasheet-for-the-pfizer-biontech-covid-19-vaccine-comirnaty-provide-sufficient-information-to-facilitate-informed-decision-making/. If you are considering this vaccine for yourself or your patients, please take the time to read this article which is referenced and followed by additional notes that discuss possible mechanisms for some of the adverse events that have been reported.)

However, despite the assurances to the public that Pfizer/BioNtech mRNA Covid-19 vaccine “COMIRNATY”  is “safe” it appears that the people who are in charge of NZ’s Pharmacovigilance Centre are under no illusions about the potential risks that the vaccine poses to recipients.

Their website https://nzphvc.otago.ac.nz/  features a prominent banner which reads: “Report Covid-19 Vaccine Adverse Events Here”.

A couple of screengrabs from the reporting form accessible through this site speak volumes about the type of “adverse events” that could occur following vaccination with Pfizer/BioNtech mRNA Covid-19 vaccine “COMIRNATY”.

NB: Anyone can report an adverse event into this system – you do not have to be a doctor or other health professional – patients (or their friends or relatives) can make a report to this system, too. 

 

Here are some of the adverse events that are listed on the form:

Screengrab from the website of the NZ Pharmacovigilance Centre

This is how the form defines serious adverse events:

Now “safe” is a relative term, but I doubt that most people consider that adverse effects such as neurological problems or a very rapid or irregular heart beat or death to be characteristic of the results of a “safe” vaccine.

All of these adverse events have been reported in people who have been vaccinated with mRNA Covid-19 vaccines overseas.

You can prove this for yourself by going to the link below and running a search for terms such as tachycardia (rapid heart beat), palpitations (irregular heart beat), paraesthesia (numbness/altered sensations) and various other neurological problems (such as seizures or Guillan-Barre Syndrome) and death.

https://medalerts.org/vaersdb/index.php 

Sadly, you will find many examples in all of these categories as reported to the United State’s VAERS reporting system.  And these may be only the tip of the iceberg – because while it is a legal requirement for physicians to report deaths from Covid-19 vaccines, not all possible adverse effects are required to be reported.

The total deaths reported into this system (as of 12 February 2021 and following vaccination with either the Pfizer/BioNtech mRNA Covid-19 (COMIRNATY) or the Moderna mRNA Covid-19 vaccine) stood at 929. 

(Update: As of 4 June 2021, 5,888 deaths have been reported to VAERS following Covid vaccinations according to this link: https://childrenshealthdefense.org/defender/vaers-data-injuries-deaths-vaccinating-5-year-olds/ This total includes deaths following injection with other manufacturers’ Covid vaccines, not Comirnaty exclusively.)

Deaths can be reported to VAERS prior to formal ascertainment that the vaccine was the cause of death so it is possible that some of these people will later be found to have died from non-vaccine related causes. 

Nonetheless, the finding that so many of the reports involve death within 48 hours of vaccination is concerning. See:   https://childrenshealthdefense.org/defender/latest-data-cdc-vaers/   

It is also concerning that as of January 29, 2021, approximately three days prior to the datasheet for COMIRNATY being published on Medsafe’s website, the VAERS system already had 501 reports of death following Covid-19 vaccination.  Of these deaths 59% occurred in recipients of COMIRNATY.   See:  https://childrenshealthdefense.org/defender/deaths-injuries-following-covid-vaccine-cdc.

Reporting an adverse event after receiving a Covid-19 vaccine

In addition to making a report to the NZ Pharmacovigilance Centre via this link https://nzphvc.otago.ac.nz/  anyone who suffers an adverse event following a Covid-19 vaccination also has the option of reporting to two overseas organisations that are collecting data [5] about vaccine adverse events.

The links to the pages on these organisations’ websites where adverse events can be reported are below:

https://www.vaxxtracker.com/

NEW Independent NZ option to report adverse reactions to Covid vaccines

The incorporated society Nga Kaitiaki Tuku Iho has established an online reporting link via which people in NZ can report adverse reactions following Covid vaccination and/or related issues (such as cases in which people are being bullied by their employer to be vaccinated with the Pfizer/BioNTech mRNA vaccine).

The general website link is here: https://kti.org.nz

The link where an adverse reaction (or workplace bullying) may be reported is here: https://kti.org.nz/?page_id=315

Some of the reports received by Nga Kaitiaki Tuku Iho to date may be read at the following link: https://kti.org.nz/?page_id=313

Concluding thoughts

The NZ government is pushing the use of the Pfizer/BioNtech mRNA Covid-19  (COMIRNATY) even before the final data collection date for the primary outcome measure for a major trial of this vaccine (August 3, 2021) has been reached. (The trial is not scheduled for completion until 2023.)  

The NZ government has ignored – or, in one case, even reduced access to – other low cost options that could be used for prevention or treatment of Covid-19. [6]

Given this sad state of affairs, it seems a good precaution to ensure that any known or suspected adverse reactions following Covid-19 vaccination in NZ are reported to organisations such as  https://childrenshealthdefense.org/covid-19-vaccine-reactions/ and https://www.vaxxtracker.com/ as well as Nga Kaitiaki Tuku Iho https://kti.org.nz/?page_id=315 that are not beholden to the NZ government for funding – as well as to the NZ Pharmacovigilance Centre. 

 

References

[1] https://www.nzherald.co.nz/nz/covid-19-coronavirus-vaccine-prime-minister-jacinda-ardern-jabs-begin-for-border-staff-next-week/FNNXTDYC777REAB226CRNXGKG4/

[2] https://www.nzherald.co.nz/nz/covid-19-coronavirus-health-workers-get-early-jabs-to-ensure-expiring-vaccinations-dont-go-to-waste/N3JLC2J45VIIGQ3XBNSXWUMH3I/

[3] https://www.nzherald.co.nz/nz/covid-19-coronavirus-why-new-vaccine-is-safe-your-questions-answered/DCRTMICVEHEKWRAICJZK5NNZYQ/

[4[ https://clinicaltrials.gov/ct2/show/record/NCT04368728 The final data collection date for the primary outcome measure for the trial of this vaccine is August 3, 2021.   Some of the study the participants are planned to be followed for up to two years after their second dose. The trial began on April 29, 2020. (Accessed February 4, 2020).

[5] Privacy protections for data submitted to organisations outside of NZ may differ from those within NZ.  The Vaxxtracker website offers the chance to report vaccine adverse events anonymously.  See:  https://childrenshealthdefense.org/defender/injured-by-vaccine-how-to-report-it/

[6] https://therealnews.nz/wp-content/uploads/2020/12/Fact-Sheet-on-TREATMENT-OPTIONS-FOR-COVID-19-including-references-and-notes-1-1.pdf