Published: 30 June 2021

COVID-19

Adverse events following immunisation with COVID-19 vaccines: Safety Report #13 – 29 May 2021

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

Introduction

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

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 29 May 2021

There were 364 non-serious and 8 serious reports this week. Sadly, two of these serious reports reported on deaths. For more information, please refer to the summary of reported deaths. No safety concerns with the Comirnaty vaccine were raised by these reports.

Three of the serious reports were described as allergic reactions, and there was one report each for deep vein thrombosis, cardiogenic syncope and haemorrhage.

Anaphylaxis

Of the three serious reports of allergic reactions this week, there was one report where the reporter indicated suspected anaphylaxis. CARM assessed these cases against the Brighton Collaboration case definition for anaphylaxis. This case was a possible Brighton anaphylaxis level 1.

Anaphylaxis is a rare adverse event that can occur with any vaccine. People giving vaccines must have medical treatment for anaphylaxis on hand, and must keep people under observation for at least 20 minutes so that anaphylaxis can be managed, if it happens.

New safety signal: Bell’s palsy/facial paralysis

As of 29 May 2021, there have been 9 reports of Bell’s palsy/facial paralysis. Medsafe is currently reviewing this signal and we will provide further information once the review is completed.

Ongoing safety signal: myocarditis

Medsafe continues to investigate this safety signal. We have published a monitoring communication to encourage further reporting of cases of myocarditis in patients who have been vaccinated with Comirnaty.

AEFI reports received by prioritised ethnicity and vaccine dose, up to and including 29 May 2021

Ethnicitya	Dose 1	Dose 2	Dose unknownb	Total
Māori	159	134	0	293
Pacific Peoples	128	104	0	232
Asian	407	305	0	712
European/Other	1,490	1,261	0	2,751
Unknownb	56	33	0	89
Total	2,240	1,837	0	4,077c

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 89 AEFI reports where the person’s ethnicity was not reported. Ethnicity and dose number are 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 29 May 2021

Age	Dose 1	Dose 2	Dose unknowna	Total
10 - 19 years	57	26	0	83
20 - 29 years	445	387	0	832
30 - 39 years	452	439	0	891
40 - 49 years	406	401	0	807
50 - 59 years	407	359	0	766
60 - 69 years	270	172	0	442
70 - 79 years	118	31	0	149
80+ years	53	8	0	61
Unknowna	32	14	0	46
Total	2,240	1,837	0	4,077b

Note:

1. There were 46 AEFI reports where the person’s age was not reported. Age and dose number are 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 29 May 2021

Reaction	Number
Headache	1,519
Dizziness	1,209
Fever	1,024
Nausea	1,001
Lethargy	948
Injection site pain	800
Musculoskeletal pain	471
Feeling of body temperature change	385
Numbness	269
Chest discomfort	255

Top 10 most frequently reported AEFIs, dose 1 only, up to and including 29 May 2021

Reaction	Number
Dizziness	716
Headache	637
Nausea	447
Fever	364
Lethargy	334
Injection site pain	275
Numbness	138
Syncope (fainting)	132
Musculoskeletal pain	127
Chest discomfort	122

Top 10 most frequently reported AEFIs, dose 2 only, up to and including 29 May 2021

Reaction	Number
Headache	882
Fever	660
Lethargy	614
Nausea	554
Injection site pain	525
Dizziness	493
Musculoskeletal pain	344
Feeling of body temperature change	288
Myalgia (muscle pain)	152
CHest disacomfort	133

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

• 4 of these deaths are unlikely related to the COVID-19 vaccine
• 1 death could not be assessed due to insufficient information
• 1 case is still under investigation.

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. There are currently no indications to suggest that the vaccine caused the deaths. To date, the observed number of deaths reported after vaccination is actually less than the expected number of deaths.

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 29 May 2021

AESI Category	AESI	Totala
Immune system disorders	Guillain-Barré Syndrome	0
	Thrombocytopenia	0
	Thrombosis with thrombocytopenia syndrome (TTS)	0
	Anaphylaxisb	13
Cardiovascular system	Myocardial infarction (heart attack)	0
	Myocarditis/pericarditis	<6
Blood and lymphatic system	Thrombosis	<6
	Embolism	<6
	Deep vein thrombosis (DVT)	<6
	Vasculitis	0
	Haemorrhage	7
Hepato-gastrointestinal and renal system	Acute kidney injury	0
	Acute liver injury	0
Nervous system	Aseptic meningitis	0
	Encephalitis	0
	Stroke	<6
	Bell's Palsy/facial paralysis	9
	Myelitis	0
Infections and musculoskeletal	Erythema multiforme	0
	Arthritis	0
	Herpes zoster	13

1. Includes all reports, both serious and non-serious. Counts below 6 are reported as <6 for privacy reasons.
2. Includes reports meeting levels 1-3 of the Brighton Collaboration case definition.

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