https://www.medsafe.govt.nz/COVID-19/safety-report-25.asp

Here is the latest Medsafe Report of Pfizer vax injuries.

A new safety signal is reported: Thrombocytopenia (ie blood clots)

I understand blood clots are what cause many heart attacks and strokes.

Thrombocytopenia (THROM-bo-sigh-toe-PEE-ne-ah) occurs when your blood platelet count is low. Platelets are also called thrombocytes. This type of blood cell clumps together to form blood clots to help stop bleeding at the site of a cut or wound. Another name for a blood clot is thrombus.

816 new non serious and 28 new serious reports in the last week!

Surely they are not all just coincidences?

AEFI reports received and vaccine doses administered, up to and including 21 August 2021

844

New AEFI reports since last update

(816 new non-serious and 28 new serious)

1

New safety signal (potential safety issue) has been identified

Thrombocytopenia

2,755,117

Total doses administered

(cumulative)

10,556

Total AEFI reports that were non-serious

458

Total AEFI reports that were serious

11,014

Total AEFI reports that were received

(cumulative)

There were 816 non-serious and 28 serious reports this week. Sadly, five of these serious reports reported on deaths.

For information about reported deaths, please refer to the summary of reported deaths section. No new safety concerns with the Comirnaty vaccine were raised by these reports.

AEFI reports received by prioritised ethnicity and vaccine dose, up to and including 21 August 2021

Ethnicitya Dose 1 Dose 2 Total

Māori 499 324 823

Pacific Peoples 280 239 519

Asian 920 616 1,536

European/Other 4,607 3,336 7,943

Unknownb 112 78 190

Total 6,418 4,593 11,011c

Notes:

The prioritised ethnicity classification system allocates each person to a single ethnic group, based on the ethnic groups they identify with. Where people identify with more than one group, they are assigned in this order of priority: Māori, Pacific Peoples, Asian, and European/Other. So, if a person identifies as being Māori and New Zealand European, the person is counted as Māori. See Ethnicity Data Protocols for further information.

There were 190 AEFI reports where the person’s ethnicity was not reported. Ethnicity is not required for an AEFI report to be considered valid. See ‘Valid report’ in the Definitions section below.

The total is different from the cumulative total above because it excludes 3 AEFI reports received for infants who did not receive the vaccine.

AEFI reports received by age band and vaccine dose, up to and including 21 August 2021

Age Dose 1 Dose 2 Total

10 - 19 years 195 71 266

20 - 29 years 904 687 1,591

30 - 39 years 1,023 836 1,859

40 - 49 years 1,087 850 1,937

50 - 59 years 1,209 844 2,053

60 - 69 years 1,060 684 1,744

70 - 79 years 630 427 1,057

80+ years 302 189 491

Unknowna 8 5 13

Total 6,418 4,593 11,011b

Note:

There were 13 AEFI reports where the person’s age was not reported. Age is not required for an AEFI report to be considered valid. See ‘Valid report’ in the Definitions section below.

The total is different from the cumulative total above because it excludes 3 AEFI reports received for infants who did not receive the vaccine.

Top 10 most frequently reported AEFIs, any dose, up to and including 21 August 2021

Reaction Number

Headache 3,567

Dizziness 3,245

Injection site pain 2,669

Lethargy 2,538

Nausea 2,425

Fever 1,653

Musculoskeletal pain 1,037

Chest discomfort 973

Numbness 855

Feeling of body temperature change 754

Top 10 most frequently reported AEFIs, dose 1 only, up to and including 21 August 2021

Reaction Number

Dizziness 2,041

Headache 1,635

Nausea 1,222

Injection site pain 1,215

Lethargy 1,082

Fever 526

Chest discomfort 522

Numbness 513

Syncope (fainting) 402

Shortness of breath 378

Top 10 most frequently reported AEFIs, dose 2 only, up to and including 21 August 2021

Reaction Number

Headache 1,932

Lethargy 1,456

Injection site pain 1,454

Dizziness 1,204

Nausea 1,203

Fever 1,127

Musculoskeletal pain 671

Feeling of body temperature change 496

Chest discomfort 451

Influenza like illness 345

Please note that one adverse event report, which represents one person, may report on more than one symptom. Reports are sent to CARM if the reporter suspects that the vaccine may have caused the event. This does not necessarily mean that the vaccine did cause the event.

The number of reports can be influenced by how many people are being vaccinated, media attention, the nature of the events (eg, how painful the vaccination was), and other factors which vary over time. Not everyone who has an adverse reaction reports it, and some people may report AEFIs after each vaccination. The information here shows the number of reports not the number of people who experienced an AEFI.

The information is limited by the information provided in the report and may change over time due to quality control procedures and/or receipt of additional information. Non-valid reports are not included in the data.

Summary of reported deaths

Up to and including 21 August 2021, a total of 37 deaths were reported to CARM after the administration of the Comirnaty vaccine. Following medical assessments by CARM and Medsafe it has been determined that:

19 of these deaths are unlikely related to the COVID-19 vaccine

5 deaths could not be assessed due to insufficient information

12 cases are still under investigation.

1 death was likely due to vaccine induced myocarditis (awaiting Coroner’s determination)

By chance, some people will experience new illnesses or die from a pre-existing condition shortly after vaccination, especially if they are elderly. Therefore, part of our review process includes comparing natural death rates to observed death rates following vaccination, to determine if there are any specific trends or patterns that might indicate a vaccine safety concern.

To date, the observed number of deaths reported after vaccination is actually less than the expected number of natural deaths.

Mortalities by age group up to and including 21 August 2021

Age Mortalities

10 - 29 years 0

30 - 59 years 6

60 - 79 years 14

80+ years 17

Adverse events of special interest

Adverse events of special interest (AESI) are pre-specified medically significant events that have the potential to be causally associated with the vaccine and must be carefully monitored. AESI can be serious or non-serious and can include:

Events of interest due to their association with COVID-19 infection.

Events of interest for vaccines in general (e.g. to the specific vaccine type or adjuvants).

The list of AESIs below takes into consideration the lists of AESIs from expert groups such as the Brighton Collaboration, manufacturers and other regulatory authorities. The AESI list changes based on the evolving safety profile of vaccines. It is important to note that although these adverse events may occur after being vaccinated with a COVID-19 vaccine in New Zealand, they are rare and may not necessarily be related to the vaccine. Medsafe and CARM review the reports to determine whether the vaccine may have played a role in the occurrence of these events.

Adverse events of special interest (AESI) up to and including 21 August 2021

AESI Category AESI Totala

Immune system disorders Guillain-Barré Syndrome <6

Thrombocytopenia 7

Thrombosis with thrombocytopenia syndrome (TTS) 0

Anaphylaxisb 34

Cardiovascular system Myocardial infarction (heart attack) 10

Myocarditis/pericarditis 32

Blood and lymphatic system Thrombosis 9

Embolism 18

Deep vein thrombosis (DVT) 26

Vasculitis <6

Haemorrhage 45

Hepato-gastrointestinal and renal system Acute kidney injury 6

Acute liver injury <6

Nervous system Aseptic meningitis 0

Encephalitis 0

Stroke 26

Bell's Palsy/facial paralysis 39

Myelitis 0

Infections and musculoskeletal Erythema multiforme <6

Arthritis 11

Herpes zoster 59

Pregnancy, puerperium and perinatal conditions Abortion (spontaneous abortion /miscarriage) <6

Includes all reports, both serious and non-serious. Counts below 6 are reported as <6 for privacy reasons. Counts may change due to receipt of additional information and subsequent reclassification of cases.

Includes reports meeting levels 1-3 of the Brighton Collaboration case definition.

Summary of safety signals

New safety signal: thrombocytopenia

Medsafe has investigated a possible safety signal of thrombocytopenia (low blood platelet count), based on seven cases reported to CARM. The data was presented to the COVID-19 Vaccine Independent Safety Monitoring Board (CV-ISMB) and there was consensus that there is insufficient evidence to suspect that the Comirnaty vaccine causes thrombocytopenia. Medsafe will continue to monitor through the usual safety monitoring processes.

Summary of Medsafe’s investigations into possible safety signals

Safety signal Outcome

Blood clots Continue to monitor. See also the Monitoring communication

Appendicitis Continue to monitor

Myocarditis/pericarditis Information has been added to Comirnaty data sheet. See also the Alert communication

Herpes zoster Continue to monitor

Bell’s palsy/facial paralysis Continue to monitor

Menstrual disorder Continue to monitor

Stroke Continue to monitor

Tinnitus Continue to monitor

AEFIs in the elderly Continue to monitor and updated data sheet

Pancreatitis Continue to monitor

Glomerular diseases Continue to monitor

Guillain-Barré Syndrome Continue to monitor

Thrombocytopenia Continue to monitor

Definitions

Adverse event following immunisation (AEFI)

An AEFI is an untoward medical event which follows immunisation and does not necessarily have a causal relationship with the administration of the vaccine. The adverse event may be an unfavourable or unintended sign, abnormal laboratory finding, symptom or disease.

Serious adverse event following immunisation

An AEFI is considered serious if it:

is a medically important event or reaction

requires hospitalisation or prolongs an existing hospitalisation

causes persistent or significant disability or incapacity

is life threatening

causes a congenital anomaly/birth defect

results in death.

It is possible for different people to have experienced the same event but for the report to be serious for one person and non-serious for another person.

Adverse events of special interest (AESI)

An AESI is a pre-specified medically significant event that has the potential to be causally associated with the vaccine product based on past experience, the technology used to make the vaccine or the infection the vaccine is used to protect against. AESIs need to be carefully monitored and any potential association to vaccination confirmed by further analysis and studies.

Safety signal

Information on a new or known adverse event that may be caused by the vaccine and requires further investigation. Safety signals can be detected from a wide range of sources such as CARM reports, clinical studies and scientific literature.

Valid report

There are only four requirements for a valid AEFI report:

one patient identifier (eg, name, initials, gender, date of birth, age)

suspect medicine(s)

suspected reaction(s)

reporter details.

These four requirements are the minimum requirements. However, including more information in the report helps Medsafe to investigate the reaction more quickly. Reporting is easiest online.

More information

See the data sheets and consumer medicine information for the expected reactions for approved COVID-19 vaccines.

COVID-19 Vaccine Safety Monitoring Process

View Ministry of Health COVID-19 vaccine data

Latest listing of all cases received

The latest listing of AEFIs received is included in the attached spreadsheet. Medsafe advises patients NOT to make any decisions about vaccination based on information contained here.

Download AEFI-line-listing.xlsm

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