Published: 1 September 2021
Archived: 21 August 2024

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COVID-19 Archive

Adverse events following immunisation with COVID-19 vaccines: Safety Report #24 – 14 August 2021

• Introduction
• Adverse events following immunisation (AEFI) reported
• Summary of reported deaths
• Adverse events of special interest
• Summary of safety signals
• Definitions
• More information

Introduction

This page provides information on the number of adverse events following immunisation (AEFI) reports received for COVID-19 vaccines.

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.

The national roll-out of COVID-19 vaccines commenced on 20 February 2021. The vaccine currently available in New Zealand is Pfizer-BioNTech (Comirnaty). All medicines can cause side effects, the known side effects for Comirnaty are listed in the data sheet and consumer medicine information.

Suspected AEFI to COVID-19 vaccines are reported to the Centre for Adverse Reactions Monitoring (CARM). The Ministry of Health (through Medsafe) contracts the collection of this information to CARM, based at the University of Otago in Dunedin. Medsafe is closely monitoring the AEFI reported from the use of the COVID-19 vaccine. Find out more about vaccine safety monitoring.

Medsafe and CARM thank everyone who has contributed to the monitoring of COVID-19 vaccines. Please continue to report any adverse events following immunisation.

Adverse events following immunisation (AEFI) reported

The information below includes:

• AEFI reports received and vaccine doses administered
• AEFI reports by prioritised ethnicity and vaccine dose
• AEFI reports by age band and vaccine dose
• the top 10 most frequently reported AEFIs by vaccine dose.

AEFI reports received and vaccine doses administered, up to and including 14 August 2021

There were 916 non-serious and 40 serious reports this week. Sadly, five of these serious reports reported on deaths.

The COVID-19 Vaccine Independent Safety Monitoring Board (CV-ISMB) has concluded its review into the death of a woman. The CV-ISMB considered the death was due to myocarditis, which is known to be a rare side effect of the Comirnaty vaccine.

The case has been referred to the Coroner and the cause of death has not yet been determined.

The CV-ISMB considered that the myocarditis was probably due to vaccination. The CV-ISMB noted that there were other medical issues occurring at the same time, which may have influenced the outcome following vaccination. The benefits of vaccination with the Comirnaty vaccine continue to greatly outweigh the risk of both COVID-19 infection and vaccine side effects, including myocarditis.

The Ministry has released a media statement and for more information about reported deaths, please refer to the summary of reported deaths section.

For information about safety signals, please refer to the summary of safety signals section.

AEFI reports received by prioritised ethnicity and vaccine dose, up to and including 14 August 2021

Ethnicitya	Dose 1	Dose 2	Total
Māori	450	299	749
Pacific Peoples	257	223	480
Asian	856	593	1,449
European/Other	4,145	3,111	7,256
Unknownb	104	73	177
Total	5,812	4,299	10,111c

Notes:

1. 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.
2. There were 177 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.
3. The total is different from the cumulative total above because it excludes 2 AEFI reports received for infants who did not receive the vaccine (see safety report 10).

AEFI reports received by age band and vaccine dose, up to and including 14 August 2021

Age	Dose 1	Dose 2	Total
10 - 19 years	154	64	218
20 - 29 years	812	660	1,472
30 - 39 years	941	798	1,739
40 - 49 years	977	791	1,768
50 - 59 years	1,048	789	1,837
60 - 69 years	988	628	1,616
70 - 79 years	602	392	994
80+ years	283	171	454
Unknowna	7	6	13
Total	5,812	4,299	10,111b

Note:

1. 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.
2. The total is different from the cumulative total above because it excludes 2 AEFI reports received for infants who did not receive the vaccine (see safety report 10).

Top 10 most frequently reported AEFIs, any dose, up to and including 14 August 2021

Reaction	Number
Headache	3,312
Dizziness	2,966
Injection site pain	2,485
Lethargy	2,337
Nausea	2,252
Fever	1,552
Musculoskeletal pain	999
Chest discomfort	873
Numbness	769
Feeling of body temperature change	717

Top 10 most frequently reported AEFIs, dose 1 only, up to and including 14 August 2021

Reaction	Number
Dizziness	1,842
Headache	1,492
Injection site pain	1,123
Nausea	1,120
Lethargy	984
Fever	482
Chest discomfort	463
Numbness	455
Syncope (fainting)	355
Musculoskeletal pain	347

Top 10 most frequently reported AEFIs, dose 2 only, up to and including 14 August 2021

Reaction	Number
Headache	1,820
Injection site pain	1,362
Lethargy	1,353
Nausea	1,132
Dizziness	1,124
Fever	1,070
Musculoskeletal pain	652
Feeling of body temperature change	474
Chest discomfort	410
Numbness	314

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 14 August 2021, a total of 31 deaths were reported to CARM after the administration of the Comirnaty vaccine. Following medical assessments by CARM and Medsafe it has been determined that:

• 17 of these deaths are unlikely related to the COVID-19 vaccine
• 4 deaths could not be assessed due to insufficient information
• 9 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 14 August 2021

Age	Mortalities
10 - 29 years	0
30 - 59 years	6
60 - 79 years	11
80+ years	14

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 14 August 2021

AESI Category	AESI	Totala
Immune system disorders	Guillain-Barré Syndrome	<6
	Thrombocytopenia	7
	Thrombosis with thrombocytopenia syndrome (TTS)	0
	Anaphylaxisb	31
Cardiovascular system	Myocardial infarction (heart attack)	10
	Myocarditis/pericarditis	26
Blood and lymphatic system	Thrombosis	9
	Embolism	16
	Deep vein thrombosis (DVT)	23
	Vasculitis	<6
	Haemorrhage	39
Hepato-gastrointestinal and renal system	Acute kidney injury	<6
	Acute liver injury	<6
Nervous system	Aseptic meningitis	0
	Encephalitis	0
	Stroke	25
	Bell's Palsy/facial paralysis	37
	Myelitis	0
Infections and musculoskeletal	Erythema multiforme	<6
	Arthritis	8
	Herpes zoster	57
Pregnancy, puerperium and perinatal conditions	Abortion (spontaneous abortion /miscarriage)	<6

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

Summary of safety signals

Summary of Medsafe’s investigations into possible safety signals

New safety signal: Guillain-Barré Syndrome

Medsafe has investigated a possible safety signal of Guillain-Barre Syndrome (GBS), based on cases (<6) reported to CARM. The data was presented to the CV-ISMB who concluded that it is difficult to assign causality to GBS cases for any vaccine but the onset time did not suggest a strong relationship to vaccination. The CV-ISMB further noted that there was not enough information to confirm that the cases reported to CARM were GBS. Medsafe will continue to monitor reported cases of GBS through the usual safety monitoring processes.

Ongoing monitoring: glomerular diseases

Medsafe has completed its investigation into glomerular diseases (diseases that affect the kidneys’ ability to balance certain substances in the blood). The data was presented to the CV-ISMB and there was consensus that there is no reason to suspect that the Comirnaty vaccine causes glomerular diseases as this stage. Medsafe will continue to monitor through the usual safety monitoring processes.

Ongoing monitoring: tinnitus

Medsafe has completed its investigation into tinnitus after receiving additional information from Pfizer. The data was presented to the CV-ISMB and it was concluded that there is currently not enough evidence to suspect that the Comirnaty vaccine causes tinnitus. Medsafe will continue to monitor reported events of tinnitus.

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

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:

1. one patient identifier (eg, name, initials, gender, date of birth, age)
2. suspect medicine(s)
3. suspected reaction(s)
4. 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