Published: 3 November 2021

COVID-19

Adverse events following immunisation with COVID-19 vaccines: Safety Report #33 – 16 October 2021

Medsafe advises people NOT to make any decisions about vaccination based on information contained in this report. If you have questions or concerns about receiving a vaccine, please speak to a health care professional.

• What you need to know
• Introduction
• Adverse events following immunisation (AEFI) reported
• Summary of reported deaths
• Observed versus expected analyses
• Adverse events of special interest
• Summary of safety signals
• Definitions
• More information

What you need to know – up to and including 16 October 2021

• The protective benefits of vaccination against COVID-19 far outweigh the potential risks of vaccination.
• The Ministry of Health, Medsafe, the Centre for Adverse Reactions Monitoring and manufacturers continue to closely monitor the safety of COVID-19 vaccines. We’ll respond to any safety issues right away and will inform New Zealanders about any risks that arise in New Zealand.
• There were 2,512 non-serious and 61 serious reports this week. Sadly, this week we have 3 more notifications of death. Any possibility of a causal link is investigated as part of our routine investigations and no new safety concerns with the Comirnaty vaccine were raised by these reports. For information about reported deaths, please refer to the summary of reported deaths section.
• Up to 16 October 2021 a total of 6,316,779 doses of Comirnaty have been administered and 30,251 AEFIs were reported. This means that more than 6.2 million doses of Comirnaty were administered that did not result in a report of an adverse event. On average for every 10,000 people who are vaccinated 48 people report an AEFI. It is also important to keep in mind that a report can be submitted for any cause and is not necessarily associated with the vaccine.

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 by prioritised ethnicity and vaccine dose
• AEFI reports by age band and vaccine dose
• the top 10 most frequently reported AEFIs by vaccine dose.
• reported AEFIs by reporter type

AEFI reports received by prioritised ethnicity and vaccine dose, up to and including 16 October 2021

Ethnicitya	Dose 1	Dose 2	Total
Māori	1,455	906	2,361
Pacific Peoples	583	434	972
Asian	2,120	1,371	3,491
European/Other	13,746	9,163	22,909
Unknownb	344	169	513
Total	18,203	12,043	30,246c

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 513 AEFI reports where the person’s ethnicity was not reported. Counts may change due to receipt of additional information. 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 5 AEFI reports received for infants who did not receive the vaccine.

AEFI reports received by age band and vaccine dose, up to and including 16 October 2021

Age	Dose 1	Dose 2	Total
10 - 19 years	2,031	707	2,738
20 - 29 years	3,559	1,872	5,431
30 - 39 years	3,786	2,382	6,168
40 - 49 years	3,034	2,308	5,342
50 - 59 years	2,716	2,212	4,928
60 - 69 years	1,768	1,443	3,211
70 - 79 years	881	773	1,654
80+ years	404	333	737
Unknowna	24	13	37
Total	18,203	12,043	30,246b

Note:

1. There were 37 AEFI reports where the person’s age was not reported. Counts may change due to receipt of additional information. 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 5 AEFI reports received for infants who did not receive the vaccine.

Top 10 most frequently reported AEFIs, dose 1 and dose 2, up to and including 16 October 2021

Download a list of the top 50 most frequently reported AEFIs (any dose)..

Reported AEFIs by reporter type up to and including 16 October 2021

Reporter type	Number of reportsa
Public Patient	10,573
CIR Vaccinator	9,443
Nurse	5,224
Other	2,925
General Practitioner	2,194
Public: On behalf of a patient	893
Pharmacist	210
Not specified	111

1. The total number here differs from the total reported cases elsewhere because a single case can contain multiple reports from different sources.

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 16 October 2021, a total of 94 deaths were reported to CARM after the administration of the Comirnaty vaccine. Following medical assessments by CARM and Medsafe it has been determined that:

• 40 of these deaths are unlikely related to the COVID-19 vaccine
• 38 deaths could not be assessed due to insufficient information
• 15 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. See below for more information about these observed-versus-expected analyses.

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 16 October 2021 reported to CARM

Age	Mortalities
10 - 29 years	2
30 - 59 years	17
60 - 79 years	44
80+ years	31

Observed-versus-expected analyses

These analyses are updated monthly. The next update is expected in Safety Report #36.

See the Observed-versus-expected analyses in Safety Report #32 for data up to 31 July 2021.

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 16 October 2021

AESI Category	AESI	Totala
Immune system disorders	Guillain-Barré Syndrome	11
	Thrombocytopenia	18
	Thrombosis with thrombocytopenia syndrome (TTS)	0
	Anaphylaxisb	74
Cardiovascular system	Myocardial infarction (heart attack)	35
	Myocarditis/pericarditis	169
Blood and lymphatic system	Thrombosis	35
	Embolism	67
	Deep vein thrombosis (DVT)	65
	Vasculitis	48
	Haemorrhage	87
Hepato-gastrointestinal and renal system	Acute kidney injury	11
	Acute liver injury	0
	Pancreatitis	<6
Nervous system	Aseptic meningitis	<6
	Encephalitis	<6
	Stroke	64
	Bell's Palsy/facial paralysis	106
	Myelitis/myelitis transverse	<6
Infections and musculoskeletal	Erythema multiforme	7
	Arthritis	32
	Herpes zoster	189
Pregnancy, puerperium and perinatal conditions	Abortion (spontaneous abortion /miscarriage)	13

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

Review of myocarditis and pericarditis cases

Myocarditis and pericarditis are rare side effects of vaccination with Comirnaty and information has been added to the data sheet and consumer medicine information. This information was added following investigations by Medsafe, other national regulators and Pfizer. Medsafe continues to closely monitor reports of myocarditis and pericarditis.

Medsafe and CARM have reviewed the reports of myocarditis and pericarditis received up to 14 October 2021. Cases where a diagnosis from a doctor was not reported were excluded as well as cases reported with an onset time greater than 30 days, since these are unlikely to be related to vaccination.

A total of 61 reports of myocarditis or pericarditis after dose one and 57 reports after dose two were reviewed (Figure 1 shows the numbers for each diagnosis).

Figure 1: Numbers of reports of myocarditis and pericarditis after dose one and dose two of Comirnaty, reports received up to 14 October 2021

In 61 reports the sex was noted as female and male in 57 reports. Ethnicity, when reported, was 84% European or other, 10.5% Asian, 4.5% Māori and 1% Pacific Peoples.

The age of those reported to have experienced myocarditis or pericarditis after dose 1 or dose 2 is shown in Figure 2.

Figure 2: Age range of people reported to have experienced myocarditis or pericarditis after vaccination, reports received up to 14 October 2021

Overall, the rate of myocarditis (including reports of myopericarditis) was 7 cases per million people vaccinated after dose one and 10 cases per million people vaccinated after dose two. Based on hospital discharge data from 2008 – 2019, on average 95 people were diagnosed with myocarditis every year

The time between vaccination and the first symptoms was generally within the first five days after vaccination (Figure 3).

Figure 3: Time between vaccination and first symptoms, reports received up to 14 October 2021

Please seek immediate medical attention if you experience new onset chest pain, shortness of breath or an abnormal heartbeat after vaccination with Comirnaty. These are potential signs of myocarditis and pericarditis.

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. Medsafe will continue to monitor this closely.
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
AEFIs in children	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