Buried Data, Broken Trust: Medsafe Ignored the Warnings

Submission to the Royal Commission of Inquiry Phase 2
Medsafe Response to Covid Vaccine Adverse Event Reports

Bill Dyet

15 February 2025

Dear Commissioner,

1. My Background:

I am an aircraft engineer, aged 62. I take an interest in important public issues, and I have been involved in minor political parties at various times in my life.

When Covid first struck NZ, I was very concerned and took as many health precautions as I could. However, by about October 2020, I became aware from overseas reports that the actual death rate from Covid was less than 1%, and mostly among the elderly. So, I relaxed my concern and precautions. When the Pfizer MRNA vaccine was eventually introduced into NZ, I became curious and later suspicious about the level of coercion and the true motivations behind the government and mainstream media attempts to promote this vaccine. I joined up with Lynda Wharton’s The Health Forum NZ and later NZDSOS to try to counter the propaganda that was being pushed upon us.

2. Medsafe CARM Reports:

Through The Health Forum NZ, I became aware of high numbers of reported adverse reactions to the Covid-19 vaccine in NZ. In America, similar adverse events were being reported on the USA CDC VAERs website. I was shocked by the high numbers of serious injuries and deaths being reported to VAERs and the fact that nothing was being done to stop the vaccine.  My attention was then drawn to our own Medsafe Centre for Adverse Reactions Monitoring (CARM) reporting system in NZ.  I closely followed the rising number of deaths on the monthly Medsafe Safety Report. By February 2022, these numbers had reached 147 deaths and 2,447 serious injuries following vaccination with the Pfizer Comirnaty Covid-19 vaccine (See References Item 1. Safety Report #40 – 31 January 2022 below).

About the same time, my friend Rob McLeod’s father had also died soon after receiving the vaccine, so Rob and I visited the Orewa Police Station on 17^th Feb 2022 where I laid a complaint against the Medsafe General Manager Chris James, under Section 157 of the Crimes Act, for failure to act to stop the vaccine. This is a fundamental failure of the whole purpose of our pharmacovigilance system, whereby strong safety signals require stopping the rollout of potentially dangerous new medicines. This safeguard was critical for the covid vaccine, as it was operating under a USA FDA Emergency Use Authorisation (EUA), having not undergone full clinical trials. After about two months of deliberation, the Police declined to investigate Medsafe. I placed an OIA with the NZ Police for their internal communications, which I have received redacted and attached to this submission at Appendix A.

3. The Purpose of CARM:

The CARM database provides New Zealand-specific information on adverse reactions to medicines and vaccines. CARM monitors and analyses the database for the identification of new signals, or important patterns, clusters or unusual events or practices that could have significance for medicine safety and prescribing practices in New Zealand. These findings are considered by Medsafe and/or the Medicines Adverse Reactions Committee (MARC). This may result in further investigation and/or formal review which can lead to emphasising or changing relevant prescribing advice or other regulatory actions aimed at ensuring the safety of medicines registered in NZ.

4. The High Numbers of Adverse Events Reports to CARM:

The number of deaths on the Medsafe Safety Report from the covid vaccine has climbed to 184 under “Summary of Reported Deaths” on the last published Safety Report number 46, on the 30^th November 2022, along with 3,688 serious injuries. (See the link below).

Safety Report #46 – 30 November 2022

Medsafe have not published any further covid vaccine Safety Reports since #46 in late 2022. They have simply given up on reporting Covid-19 vaccine adverse events! Medsafe also claims to have investigated the reported deaths and only attributes three to the vaccine.

These high numbers of reports are not the total of all adverse events in NZ from the covid vaccine either. Medsafe themselves state that adverse event reporting is typically only around 5% of total adverse events (See References Item 2).  So, despite the high numbers, these are just the tip of a huge iceberg!

5. How to Carry Out an Independent Review of the Reports to CARM:

In early 2022, I asked through an OIA request for the covid vaccine adverse event death reports from Medsafe (with personal information redacted) so that I could arrange with medical experts within NZDSOS to conduct independent reviews of these reports to establish any causality between the vaccine and the deaths, (which the report submitters clearly believed to be the case). This request was declined by Medsafe.  However, I have recently been able to gain access to all these reports anyway, as follows: 

At the bottom of the Safety Report #46 in the link above, click the link below:

On the AEFI Spreadsheet “Sheet 1” tab you will see that there are 249,903 separate AEFI line-item reports of various harms to New Zealanders from the covid vaccine! And yet, the vaccine has still not been withdrawn to this day.

The individual reports for each of these nearly 250,000 AEFI numbers can be downloaded from the USA CDC website as follows:

1. Go to the link below:

https://www.vaersaware.com/new-zealand

2. Click the MedAlerts button:

3. Enter the individual AEFI number from the Spreadsheet and click ‘Apply’:

4. Click the VAERS number link that comes up (2704381 in this case):

5. The detailed individual report is then downloaded from VAERS as per the example below.

I have now downloaded most of the serious reports and those linked with deaths, onto a spreadsheet that I have available if requested. See Appendix B for a sample of these line-item reports.  You will see from the serious nature of these reports and their close temporal links to the associated vaccination dates (“Effect date” vs “Jab date”) that it is unlikely that Medsafe have seriously investigated any of these, despite claiming to have done so in their Safety Reports. In the case of my friend Rob’s father, who died from the vaccine and was reported to CARM, Rob was never contacted by anyone conducting an investigation.

6. The Failure of our Medsafe CARM Pharmacovigilance System:

All of this highlights a more fundamental problem with the whole approach from Medsafe. What should have happened with a robust pharmacovigilance system, is that the vaccine roll-out should have been stopped following the initial reports of deaths and then only recontinued after those deaths were thoroughly investigated and found to have NOT been caused by the vaccine. Instead, Medsafe allowed the roll-out to continue unless it was proven beyond doubt that all these deaths WERE caused by the vaccine. This is simply placing the burden of proof the wrong way around and doesn’t even account for the high numbers of reported serious injuries apart from the reported deaths. I also know from the case of Rob’s father and the death of another person, that these investigation claims by Medsafe are fraudulent. Medsafe have allowed the vaccine rollout to continue despite these overwhelming reports and are therefore no longer fit for purpose.

7. Recommendations:

The Royal Commission of Inquiry must investigate Medsafe’s response to the vaccine adverse events because we now have a non-functioning pharmacovigilance system in NZ that is failing to protect the public from harmful medicines. The investigation needs to include Discovery of internal communications within Medsafe and MARC as well as any recommendations from Medsafe to the Minister of Health and/or the Director General of Health concerning the high numbers of adverse events from the Covid-19 vaccination and recommended suspension of the vaccine rollout. Was the Minister advised and then chose to do nothing, or does the blame lie solely with Medsafe?

The Inquiry also needs to investigate any possible influence, through funding or other means that the pharmaceutical industry may have over Medsafe, to fully understand the motivations behind the cover-up behaviour of Medsafe.

Regards,
Bill Dyet

References:

1. Safety Report #40 – 31 January 2022
2. https://www.medsafe.govt.nz/profs/PUArticles/ADRreport.htm
3. Safety Report #46 – 30 November 2022

Appendix A: Redacted Police Complaint Internal Correspondence

Appendix B. AEFI Reports

A selection of the more serious reports. I have these available on a separate spreadsheet if requested.

Spreadsheet column titles:

AEFI Case number. Preferred term VAERS #. AGE. Result Jab date. Effect date

Spreadsheet reports:  

AEFI-A-027391 Cardiac arrest (10007515)    1796940     17      DEATH     30/08/2021     9/09/2021     Cardiac arrest; This is a spontaneous report from a contactable consumer from the regulatory authority. The regulatory authority report number is AEFI-A-027391. A 17-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 30Aug2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included hospitalisation from an unknown date and unknown if ongoing. The patient’s concomitant medications were not reported. The patient previously took oral contraceptive NOS and experienced pulmonary embolism. On 09Sep2021 at 14:30, the patient experienced cardiac arrest and died. The event was reported as serious (death). The course of the event was reported as follows (according to AEFI): Cardiac arrest and subsequent death. The circumstances are that this 17-year-old was admitted to the PRIVACY where a diagnosis of pulmonary embolism was made attributed by the clinicians to be due to Combined Oral Contraceptives that have been started in July 2021 (i.e. 2/12 earlier). Sadly, the PE was fatal, and this young person died in hospital. The hospital diagnosed this event as due to the COC and the case was referred to the Forensic Pathologist as suspected due to the COC. A vaccine aetiology was not considered. APCR suggests Factor V Leiden. It was not reported if an autopsy was performed. The patient died on 09Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest

AEFI-A-067953 Cardiac arrest (10007515)     2195671     20     LT      9/02/2022     14/02/2022     Cardiac arrest; Pericarditis; Chest discomfort; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from Regulatory Authority. Regulatory number: AEFI-A-067953. A 20 year-old male patient received bnt162b2 (COMIRNATY), administration date 09Feb2022 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1), for COVID-19 immunisation. The following information was reported: CARDIAC ARREST (medically significant, life threatening) with onset 14Feb2022 03:00, outcome “not recovered”, described as “Cardiac arrest”; PERICARDITIS (medically significant, life threatening) with onset 14Feb2022 03:00, outcome “not recovered”, described as “Pericarditis”; CHEST DISCOMFORT (life threatening) with onset 14Feb2022 03:00, outcome “not recovered”, described as “Chest discomfort”. Clinical course: around 3am he was waken a pain in left chest Pain worse on deep breathing, not radiating Nil fever, cough, palpitations, SOB. Chest clear on auscultation. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

AEFI-A-030657 Cardiac failure (10007554)     1820065     20     Hosp     15/09/2021     15/09/2021     Cardiac failure; chest discomfort; Multiple organ dysfunction syndrome; Myocarditis/ peri-myocarditis; Pericarditis; Tachycardia; cardiomyopathy secondary to her Friedreich Ataxia (even though normal echo last year), but was getting worse in the last few days and much worse after the vaccine; cardiomyopathy secondary to her Friedreich Ataxia (even though normal echo last year), but was getting worse in the last few days and much worse after the vaccine; This is a spontaneous report from a contactable consumer from the Medsafe. Regulatory authority report number is AEFI-A-030657. A 20-year-old female patient received the first dose of bnt162b2 (COMIRNATY) on 15Sep2021 (lot number: unknown) (at the age of 20-years-old) via unknown route of administration at single dose for COVID-19 immunisation. Medical history included chest discomfort, cardiomyopathy secondary to her Friedreich Ataxia and concomitant medications were not reported. On 15Sep2021 at 11:56, patient experienced Cardiac failure, Chest discomfort, Multiple organ dysfunction syndrome, Myocarditis/ peri-myocarditis, Pericarditis, Tachycardia. Patient started to have chest discomfort before getting the vaccine. Was presented to ED at the day of vaccination with chest pain. She was diagnosed with peri-myocarditis. A day later she has deteriorated with multi organ failure and she was in ICU now. She had cardiomyopathy secondary to her Friedreich Ataxia (even though normal echo last year), but was getting worse in the last few days and much worse after the vaccine. Symptoms were not necessarily secondary to the vaccine and started before with no doubt. The outcome of the events was not recovered. This report was considered serious due to hospitalization. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

AEFI-A-038827 Cardiac failure (10007554)     2700429     27     DEATH     8/10/2021     9/10/2021     Chest discomfort; Sinusitis; Dyspnoea; Cardiac failure; Lymphadenopathy; Influenza like illness; Fatigue; Injection site pain; Pulmonary embolism; Headache; Pneumonia; Wheezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: AEFI-A-038827. A 27-year-old female patient received bnt162b2 (COMIRNATY), on 08Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (death), 23 hrs after the suspect product(s) administration, outcome “fatal”; SINUSITIS (death), 23 hrs after the suspect product(s) administration, outcome “fatal”; DYSPNOEA (death), 23 hrs after the suspect product(s) administration, outcome “fatal”; CARDIAC FAILURE (death, medically significant), 23 hrs after the suspect product(s) administration, outcome “fatal”; LYMPHADENOPATHY (death), 23 hrs after the suspect product(s) administration, outcome “fatal”; INFLUENZA LIKE ILLNESS (death), 23 hrs after the suspect product(s) administration, outcome “fatal”; FATIGUE (death), 23 hrs after the suspect product(s) administration, outcome “fatal”; VACCINATION SITE PAIN (death), 23 hrs after the suspect product(s) administration, outcome “fatal”, described as “Injection site pain”; PULMONARY EMBOLISM (death, medically significant), 23 hrs after the suspect product(s) administration, outcome “fatal”; HEADACHE (death), 23 hrs after the suspect product(s) administration, outcome “fatal”; PNEUMONIA (death, medically significant), 23 hrs after the suspect product(s) administration, outcome “fatal”; WHEEZING (death), 23 hrs after the suspect product(s) administration, outcome “fatal”. The patient date of death was unknown. Reported cause of death: “Lymphadenopathy”, “Chest discomfort”, “Sinusitis”, “Dyspnoea”, “Cardiac failure”, “Influenza like illness”, “Fatigue”, “Injection site pain”, “Pulmonary embolism”, “Headache”, “Pneumonia”, “Wheezing”. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Chest discomfort; Sinusitis; Dyspnoea; Cardiac failure; Influenza like illness; Fatigue; Injection site pain; Pulmonary embolism; Headache; Pneumonia; Wheezing; Lymphadenopathy

AEFI-A-068264 Cardiac failure (10007554)     2208390     22     Hosp     13/10/2021     15/10/2021     Chest discomfort; Myocardial infarction; Myocarditis; Palpitations; Chest pain; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: AEFI-A-068264. A 22 year-old male patient received bnt162b2 (COMIRNATY), administration date 13Oct2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: CHEST DISCOMFORT (hospitalization) with onset 15Oct2021 15:52, outcome “recovering”, described as “Chest discomfort”; MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset 15Oct2021 15:52, outcome “recovering”, described as “Myocardial infarction”; MYOCARDITIS (hospitalization, medically significant) with onset 15Oct2021 15:52, outcome “recovering”, described as “Myocarditis”; PALPITATIONS (hospitalization) with onset 15Oct2021 15:52, outcome “recovering”, described as “Palpitations”; CHEST PAIN (hospitalization) with onset 15Oct2021 15:52, outcome “recovering”, described as “Chest pain”. Clinical course: chest tightness which progressed over a few weeks to severe chest pains. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

AEFI-A-009391 Cardiac arrest (10007515)     1710522     37     DEATH     2/07/2021     25/08/2021     chest pain; Dyspnoea; Sudden death; Syncope; This is a spontaneous report from a contactable physician (general practitioner). Regulatory authority report number is AEFI-A-009391. A 37-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 02Jul2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient’s concomitant medications were not reported. On 11Jul2021 15:05, patient developed chest pain and shortness of breath (dyspnoea) secondary to syncope, sudden death, the events resulted in death. The patient died on 25Aug2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: chest pain; dyspnoea; sudden death; syncope

AEFI-A-025016 Cardiac failure (10007554)     2702087     36     LT     30/08/2021     30/08/2021     Cardiac failure; Anxiety; Chest discomfort; Dyspnoea; Lethargy; Musculoskeletal pain; Palpitations; Tremor; Urticaria; This is a spontaneous report received from contactable reporters (Physician and Consumer or other non HCP) from Regulatory Authority. Regulatory number: AEFI-A-025016 (RA). A 36-year-old male patient received bnt162b2 (COMIRNATY), on 30Aug2021 as dose number unknown, single (batch/lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious) with onset 30Aug2021 at 08:00, outcome “not recovered”; CARDIAC FAILURE (medically significant) with onset 30Aug2021 at 08:00, outcome “not recovered”; CHEST DISCOMFORT (non-serious) with onset 30Aug2021 at 08:00, outcome “not recovered”; DYSPNOEA (non-serious) with onset 30Aug2021 at 08:00, outcome “not recovered”; LETHARGY (non-serious) with onset 30Aug2021 at 08:00, outcome “not recovered”; MUSCULOSKELETAL PAIN (non-serious) with onset 30Aug2021 at 08:00, outcome “not recovered”; PALPITATIONS (non-serious) with onset 30Aug2021 at 08:00, outcome “not recovered”; TREMOR (non-serious) with onset 30Aug2021 at 08:00, outcome “not recovered”; URTICARIA (non-serious) with onset 30Aug2021 at 08:00, outcome “not recovered”. Additional Information: case was assessed non-serious by regulatory authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

AEFI-A-027056 Cardiac failure (10007554)     1820029     35     Hosp     9/02/2021     15/09/2021     palpitations; Pleuritic pain; Atrial fibrillation; Cardiac failure; chest discomfort; Dyspnoea; injection site pain; lethargy; This is a spontaneous report from a contactable consumer from the RA. Regulatory authority report number is AEFI-A-027056. A 35-year-old female patient received bnt162b2 (COMIRNATY), second single dose via an unspecified route of administration on 09Sep2021 (Batch/Lot number was not reported) for covid-19 immunisation. The patient’s medical history and concomitant medications were not reported. The patient experienced atrial fibrillation, cardiac failure, chest discomfort, dyspnoea, injection site pain, lethargy, and pleuritic pain on 10Sep2021 at 18:25. The patient experienced palpitations on 13Sep2021. The events reported as serious as hospitalization. After the vaccination, next day (on 10Sep2021 at 18:25), the patient developed arm pain and lethargy. Then on 13Sep2021, patient developed palpitations admitted to hospital on Wednesday 15Sep2021, found to be in new atrial fibrillation requiring cardioversion. Outcome of the events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected

AEFI-A-050827 Cardiac failure (10007554)     1978241     30     Hosp     17/11/2021     20/11/2021     Cardiac failure; Myocarditis; Chest discomfort; Eye pain; Headache; Influenza like illness; Musculoskeletal pain; Nausea; Pyrexia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from Regulatory Authority. Regulatory number: AEFI-A-050827 (RA). A 30-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (1st single dose), for COVID-19 immunization. The following information was reported: CARDIAC FAILURE (medically significant) with onset 17Nov2021 20:26, outcome not recovered, described as Cardiac failure; MYOCARDITIS (medically significant) with onset 17Nov2021 20:26, outcome not recovered, described as Myocarditis; CHEST DISCOMFORT (medically significant) with onset 17Nov2021 20:26, outcome not recovered, described as Chest discomfort; EYE PAIN (medically significant) with onset 17Nov2021 20:26, outcome not recovered, described as Eye pain; HEADACHE (medically significant) with onset 17Nov2021 20:26, outcome not recovered, described as Headache; INFLUENZA LIKE ILLNESS (medically significant) with onset 17Nov2021 20:26, outcome not recovered, described as Influenza like illness; MUSCULOSKELETAL PAIN (medically significant) with onset 17Nov2021 20:26, outcome not recovered, described as Musculoskeletal pain; NAUSEA (medically significant) with onset 17Nov2021 20:26, outcome not recovered, described as Nausea; PYREXIA (medically significant) with onset 17Nov2021 20:26, outcome not recovered, described as Pyrexia. The patient underwent the following laboratory tests and procedures: body temperature: (17Nov2021) pyrexia; magnetic resonance imaging heart: (unspecified date) currently awaiting a cardiac MRI. Clinical course: Reporter’s description of AEFI: Fever, headache, sore eyes and nausea started 5 hours after 2nd COVID vaccine on 17/11/21 Experiences sharp central chest pain on 20/11/21 and was brought in by ambulance for further investigations. Found to have new diagnosis heart failure with echo evidence of suspected myocarditis, currently awaiting a cardiac MRI. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

AEFI-A-051663 Cardiac failure (10007554)     2706389     39     Med sig     4/08/2021     4/08/2021     Cardiac failure; Palpitations; Oedema peripheral; Chest discomfort; Dyspnoea; Dizziness; Headache; Fatigue; Hypertension; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) from Regulatory Authority. Regulatory number: AEFI-A-051663. A 39-year-old female patient received bnt162b2 (COMIRNATY), on 04Aug2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FAILURE (medically significant) with onset 04Aug2021, outcome “not recovered”; CHEST DISCOMFORT (non-serious) with onset 04Aug2021, outcome “not recovered”; DIZZINESS (non-serious) with onset 04Aug2021, outcome “not recovered”; DYSPNOEA (non-serious) with onset 04Aug2021, outcome “not recovered”; FATIGUE (non-serious) with onset 04Aug2021, outcome “not recovered”; HEADACHE (non-serious) with onset 04Aug2021, outcome “not recovered”; HYPERTENSION (non-serious) with onset 04Aug2021, outcome “not recovered”; OEDEMA PERIPHERAL (non-serious) with onset 04Aug2021, outcome “not recovered”; PALPITATIONS (non-serious) with onset 04Aug2021, outcome “not recovered”. Additional Information: case was assessed non-serious by Regulatory Authority. Onset: 17h No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

AEFI-A-035533 Cardiac arrest (10007515)     1796949     47     DEATH     16/09/2021     29/09/2021     Cardiac arrest; multi-organ failure; This is a spontaneous report from a contactable pharmacist via the Regulatory Authority; report number is AEFI-A-035533. A 47 (unit not reported) female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 16Sep2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient’s medical history was not reported. Concomitant medications included trimethoprim for 3 days taken for an unspecified indication from 25Sep2021 to 28Sep2021; omega 6 triglycerides, omega 9 triglycerides, omega-3 triglycerides (OMEGA 3-6-9); lactobacillus acidophilus (ACIDOPHILUS); curcumin; camellia sinensis leaf (GREEN TEA LEAF EXTRACT); magnesium; Vitamin B6; multivitamins; all taken for an unspecified indication, start and stop dates were not reported. The patient experienced cardiac arrest and multi-organ failure on 29Sep2021. The course of the event was as follows: Patient found unresponsive, unconscious and cyanosed in toilet at home around midnight on 29Sep2021. Husband started CPR and ambulance response time to scene 5-7 minutes. Intially, patient had asystole – 2 doses of adrenaline given -PEA- then ROSC. Total down time approximately 15 minutes. Intubated by ambulance staff at scene then sent to hospital ICU. Husband did not believe patient had taken any overdoses of medications. No recent medications dispensed apart from trimethoprim for 3 days on 25Sep2021 (only other medications patient takes are OTC supplements including omega 3-6-9, acidophilus, curcumin, green tea leaf extract, magnesium, vitamin B6 and multivitamins). CTH showed global hypoxic brain injury with no signs of haemorrhage and focal lesion. CTPA showed no PE, moderate L, pneumothorax and bilateral rib fractures. Patient developed multi-organ failure, decision made for palliation in the morning on 29Sep2021 on ward round at around 08:30. Patient extubated and confirmed time of death at 09:29 on 29Sep2021. Asked by intensivist to report this as there were no precipitating cause to this event that he can think of and patient had recent second dose of COVID-19 vaccine on 16Sep2021. The case was reported as serious as the events resulted to patient’s hospitalization and death. The outcome of the events was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Reported Cause(s) of Death: Cardiac arrest; multi-organ failure

AEFI-A-038051 Cardiac arrest (10007515)     1907921     52     DEATH     12/08/2021     18/08/2021     Cardiac arrest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: AEFI-A-038051 (Case Number) A 52 year-old male patient received bnt162b2 (COMIRNATY), administration date 12Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: “MS” (unspecified if ongoing). Concomitant medication(s) included: TECFIDERA taken for multiple sclerosis. The following information was reported: CARDIAC ARREST (death, medically significant) with onset 18Aug2021 12:00, outcome “fatal”, described as “Cardiac arrest”. The patient date of death was 18Aug2021. The reported cause of death was cardiac arrest. The autopsy revealed “severe narrowing of 2 major coronary arteries and moderate narrowing of 2 others” (coronary artery stenosis). The reporter don’t believe his death is vaccine related, but due to coronary artery disease. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender’s Comments: As there is limited information in the case provided, the causal association between the event CARDIAC ARREST and the suspect vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of Death: Severe narrowing of 2 major coronary arteries and moderate narrowing of 2 others

AEFI-A-048321 Cardiac arrest (10007515)     1960909     56     DEATH     1/09/2021     13/09/2021     Significant coronary artery atherosclerosis; Cardiac arrest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: AEFI-A-048321 Case Number. A 56 year-old male patient received bnt162b2 (COMIRNATY), administration date 01Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC ARREST (death, medically significant) with onset 13Sep2021, outcome “fatal”, described as “Cardiac arrest”; ARTERIOSCLEROSIS CORONARY ARTERY (death), outcome “fatal”, described as “Significant coronary artery atherosclerosis”. The patient date of death was 13Sep2021. The reported cause of death was cardiac arrest, arteriosclerosis coronary artery. This was predated the COVID vaccines (which dose was unspecific). I do not believe the Covid vacc has contributed to cause of death, but I am reporting given the temporal association. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Significant coronary artery atherosclerosis; Cardiac arrest

AEFI-A-049023 Cardiac arrest (10007515)     1960892     58     DEATH     11/08/2021     13/08/2021      ischemic heart disease; Cardiac arrest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: AEFI-A-049023 (RA Case Number). A 58 year-old female patient received bnt162b2 (COMIRNATY), administration date 11Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL ISCHAEMIA (death) with onset 13Aug2021 07:17, outcome “fatal”, described as “ischemic heart disease”; CARDIAC ARREST (death) with onset 13Aug2021 07:17, outcome “fatal”, described as “Cardiac arrest”. The patient date of death was 13Aug2021. The reported cause of death was cardiac arrest, myocardial ischaemia. PM shows COD as ischemic heart disease. No evidence of vaccine related pathologies. Outcome: Died- unrelated to Med. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender’s Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: Cardiac arrest; ischemic heart disease

AEFI-A-061597 Cardiac arrest (10007515)     2159832     57     DEATH     3/12/2021     5/12/2021     Cardiac arrest; This is a spontaneous report received from a contactable Health Professional from Regulatory Authority. Regulatory number: AEFI-A-061597. A 57 year-old female patient received the third booster dose of BNT162B2 (COMIRNATY), as single dose on 03Dec2021 for covid-19 immunization. The patient’s relevant medical history and concomitant medications were not reported. The patients vaccination history included the first and second dose of BNT162B2 (COMIRNATY), for COVID-19 immunization on unspecified dates. On 05Dec2021, at 04:15, the patient experienced cardiac arrest, which was serious as it had fatal outcome. Details were as follows: Sudden death was noted. Per the responsible forensic pathologists, it was not believed that the death was contributed to by the vaccination but are reporting the death due to the temporal association of the vaccination. It was believed, that the patient died due to an exacerbation of atherosclerotic cardiovascular disease. The outcome of death was noted as unrelated to the medication. The patient date of death was unknown. The reported cause of death was arteriosclerosis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: an exacerbation of atherosclerotic cardiovascular disease

AEFI-A-012023 Cardiac failure (10007554)     1739651     53     Perm dis     28/07/2021     6/08/2021     cardiac failure/ejection fraction of 15%; Acute kidney injury; Embolism; Abdominal pain; bilateral renal emboli; This is a spontaneous report from a contactable physician via the Regulatory Authority (Regulatory authority number AEFI-A-012023). A 53-years-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 28Jul2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced abdominal pain, acute kidney injury, cardiac failure, embolism, bilateral renal emboli on 06Aug2021 12:58. Abdominal pain ++, ambulance called -$g needed opiates. Transferred to hospital. Noted ot have bilateral renal emboli. Echo of his heart showed ejection fraction of 15% and heart as the source. Seriousness was persisting disability. Outcome of events were recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

AEFI-A-056579 Cardiac failure (10007554)     2087000     52     DEATH     31/10/2021     12/11/2021     Sudden death; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: AEFI-A-056579 (Case Number). A 52 year-old male patient received bnt162b2 (COMIRNATY), administration date 31Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: SUDDEN DEATH (death) with onset 12Nov2021 03:30, outcome “fatal”, described as “Sudden death”. The patient date of death was 12Nov2021. The reported cause of death was sudden death. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Sudden death

AEFI-A-046637 Cardiac arrest (10007515)     1960900     65     DEATH     31/08/2021     14/09/2021     DIC; Cardiac arrest; Multiple organ dysfunction syndrome / multiorgan failure; Massive Pulmonary embolism; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: AEFI-A-046637 (RA Case Number). A 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 31Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC ARREST (death) with onset 14Sep2021 16:24, outcome “fatal”, described as “Cardiac arrest”; MULTIPLE ORGAN DYSFUNCTION SYNDROME (death) with onset 14Sep2021 16:24, outcome “fatal”, described as “Multiple organ dysfunction syndrome / multiorgan failure”; PULMONARY EMBOLISM (death) with onset 14Sep2021 16:24, outcome “fatal”, described as “Massive Pulmonary embolism”; DISSEMINATED INTRAVASCULAR COAGULATION (medically significant), outcome “unknown”, described as “DIC”. The patient date of death was unknown. The reported cause of death was cardiac arrest, multiple organ dysfunction syndrome, pulmonary embolism. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest; Multiple organ dysfunction syndrome; Pulmonary embolism

AEFI-A-058075 Cardiac arrest (10007515)     2087001     63      DEATH     30/08/2021     9/10/2021     Sudden death; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional) from Regulatory Authority. The reporter is the patient. Regulatory number: AEFI-A-058075. A 63 year-old male patient received bnt162b2 (COMIRNATY), administration date 30Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: SUDDEN DEATH (death, medically significant) with onset 09Oct2021 13:15, outcome “fatal”, described as “Sudden death”. The patient date of death was 09Oct2021. The reported cause of death was “Sudden death”. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Sudden death

AEFI-A-058828 Cardiac arrest (10007515)     2089596      67     DEATH     13/12/2021     5/01/2022     Cardiac arrest; This is a spontaneous report received from a contactable reporter (Physician) from Regulatory Authority. Regulatory number: AEFI-A-058828 (Case Number). A 67-year-old male patient received bnt162b2 (COMIRNATY), administration date 13Dec2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC ARREST (death, medically significant) with onset 05Jan2022 01:30, outcome “fatal”, described as “Cardiac arrest”. Therapeutic measures were taken as a result of cardiac arrest. The patient date of death was unknown. The reported cause of death was cardiac arrest. Reporter’s description of AEFI: Collapsed outside practice at 8:30 am. Wife reports he had complained of chest pain overnight. Pulseless. CPR commenced. Found to be in asystole initially, with further CPR fine VF but then back into asystole. Declared dead at 09:30. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest

AEFI-A-035345 Cardiac failure (10007554)     1789704     69     DEATH     14/05/2021     23/05/2021     Cerebrovascular accident; Syncope; Chest discomfort; Dyspnoea; Fatigue; Hyperhidrosis; Lethargy; Muscular weakness; Pyrexia; Restlessness; Wheezing; This is a spontaneous follow up report from a contactable consumer from the Regulatory Authority; report number is AEFI-A-035345. A 69-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: unknown), via an unspecified route of administration on 14May2021 at single dose for COVID-19 immunisation. The patient’s medical history and concomitant medications were not reported. On 23May2021 at 09:00, the patient experienced cerebrovascular accident, chest discomfort, dyspnoea, fatigue, hyperhidrosis, lethargy, muscular weakness, pyrexia, restlessness, syncope, wheezing. After the first vaccine, she had become bedridden as she was suffering what she described as “asthma” like symptoms (some difficulty breathing, wheezing, very tired…). Patient did not have asthma. Seriousness criteria was death. Outcome of events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cerebrovascular accident; Chest discomfort; Dyspnoea; Fatigue; Hyperhidrosis; Lethargy; Muscular weakness; Pyrexia; Restlessness; Syncope; Wheezing

AEFI-A-010227 Cardiac arrest (10007515)     1710525     77     DEATH     30/07/2021    
Cardiac arrest; severe aortic stenosis; This is a spontaneous report from a contactable consumer (on behalf of a patient) via regulatory authority. Regulatory authority report number is AEFI-A-010227. A 77-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 23Jul2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient’s concomitant medications were not reported. The patient experienced cardiac arrest, severe aortic stenosis on 30Jul2021 21:00. The events resulted in death- unclassifiable. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: severe aortic stenosis; Cardiac arrest

AEFI-A-024122 Cardiac arrest (10007515)     2087008     77      DEATH      4/08/2021 congestive heart failure; Cardiac arrest; Sudden death; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: AEFI-A-024122 (AEFI Case number). A 77 year-old male patient received bnt162b2 (COMIRNATY), administration date 21Jul2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1), for COVID-19 immunisation. The following information was reported: CARDIAC ARREST (death) with onset 04Aug2021 12:00, outcome “fatal”, described as “Cardiac arrest”; SUDDEN DEATH (death) with onset 04Aug2021 12:00, outcome “fatal”, described as “Sudden death”; CARDIAC FAILURE CONGESTIVE (death), outcome “fatal”, described as “congestive heart failure”. The patient date of death was 04Aug2021. The reported cause of death was cardiac arrest, sudden death, cardiac failure congestive. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest; Sudden death; congestive heart failure

AEFI-A-032360 Cardiac arrest (10007515)     1796943     74     DEATH     26/08/2021     27/08/2021     Cardiac failure; Pneumonia; Cough; Dyspnoea; SOBOE; This is a spontaneous report from a contactable physician via the regulatory authority. Regulatory authority report number is AEFI-A-032360. A 74-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 26Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cardiac failure, pneumonia, cough, dyspnoea, SOBOE all on 27Aug2021 12:00. There was reported cough and SOBOE. Eventually worsened and admitted to on 07Sep2021 with severe heart failure and pneumonia from CXRs. Patient died on 09Sep2021. The patient was hospitalized for cardiac failure, pneumonia, cough, dyspnoea, and SOBOE from 07Sep2021 to an unknown date. The outcome of events was fatal (unrelated to Med, as reported). It was not reported if an autopsy was performed. The events were all reported as fatal and serious for hospitalization. Events of cardiac failure and pneumonia were also reported as medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender’s Comments: Based on the current information available and considering drug-event temporal association a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported fatal events of Cardiac failure, Pneumonia, Cough, Dyspnoea and Dyspnoea on exertion. The case will be reassessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: SOBOE; Pneumonia; Cough; Dyspnoea; Cardiac failure

AEFI-A-047492 Cardiac arrest (10007515)     1960911     DEATH    1/06/2020     28/07/2021     Cardiac arrest; Arterial thrombosis; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from Regulatory Authority. Regulatory number: AEFI-A-047492. A 70-year-old female patient received bnt162b2 (COMIRNATY), administration date 01Jun2020 (Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient”s relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC ARREST (death, medically significant) with onset 28Jul2021 17:00, outcome “fatal”, described as “Cardiac arrest”; ARTERIAL THROMBOSIS (death) with onset 28Jul2021 17:00, outcome “fatal”, described as “Arterial thrombosis”. The patient date of death was unknown. Patient (reporter”s mum) went into cardiac arrest and died. Blood clot in her carotid artery. “Unsure on the date of the vaccine but was between 2-3 weeks before”. Patient died – “unrelated to Med”. The reported cause of death was cardiac arrest, arterial thrombosis. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest; Arterial thrombosis

AEFI-A-048916 Cardiac arrest (10007515)     1960890     DEATH     3/11/2021     3/11/2021     Cardiac arrest; Arrhythmia; VT; VF; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from Regulatory Authority. Regulatory number: AEFI-A-048916 (RA Case Number). A 77-year-old male patient received bnt162b2 (COMIRNATY), administration date 03Nov2021 (Lot number: unknown) at the age of 77 years as dose 2, single for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for covid-19 immunisation. The following information was reported: CARDIAC ARREST (death, medically significant) with onset 03Nov2021 12:02, outcome “fatal”, described as “Cardiac arrest”; ARRHYTHMIA (death, medically significant) with onset 03Nov2021 12:02, outcome “fatal”, described as “Arrhythmia”; VENTRICULAR TACHYCARDIA (death, medically significant) with onset 03Nov2021 12:02, outcome “fatal”, described as “VT”; VENTRICULAR FIBRILLATION (death, medically significant) with onset 03Nov2021 12:02, outcome “fatal”, described as “VF”. Patient experienced cardiac arrest (VT and VF) and death. Patient died – unclassifiable. The patient date of death was unknown. The reported cause of death was cardiac arrest, arrhythmia, ventricular tachycardia, ventricular fibrillation. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Arrhythmia; Cardiac arrest; VT; VF

AEFI-A-075128 Cardiac arrest (10007515)     2293779     DEATH     15/01/2022     16/01/2022     Cardiac arrest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: AEFI-A-075128. A 76-year-old male patient received BNT162b2 (COMIRNATY), on 15Jan2022 at 10:59 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient”s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1 and 2; MANUFACTURER UNKNOWN). The following information was reported: CARDIAC ARREST (death, medically significant) with onset 16Jan2022 at 21:00, outcome “fatal”. The patient date of death was unknown. Reported cause of death: “cardiac arrest”. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: cardiac arrest