Published: 23 June 2021

COVID-19

Adverse events following immunisation with COVID-19 vaccines: Safety Report #12 – 22 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.

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 22 May 2021

There were 469 non-serious and 24 serious reports this week. Sadly, one of these serious reports reported on the death of one person. The death is considered by CARM, Medsafe and medical staff involved to be unrelated to the vaccine but was reported through an abundance of caution.

Furthermore, five of the serious reports were described as allergic reactions, 4 reports were for reactogenicity reactions (flu-like symptoms) and 3 reports were for pulmonary embolism. Of the remaining 12 reports, there was one report each for: stroke, palpitations, myopericarditis, seizure, taste perversion, haemorrhage, persisting fatigue, facial palsy, eye infection, deep vein thrombosis, impaired consciousness and tachycardia.

Anaphylaxis

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.

Of the 5 serious reports of allergic reactions this week, there was 1 report where the reporter indicated suspected anaphylaxis. CARM assessed this case against the Brighton Collaboration case definition for anaphylaxis. This case was a possible Brighton anaphylaxis level 1.

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 22 May 2021

Ethnicitya	Dose 1	Dose 2	Dose unknown	Total
Māori	146	113	0	259
Pacific Peoples	120	91	0	211
Asian	393	279	0	672
European/Other	1,381	1,109	0	2,490
Unknownb	43	30	0	73
Total	2,083	1,622	0	3,705c

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 73 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 22 May 2021

Age	Dose 1	Dose 2	Dose unknowna	Total
10 - 19 years	55	24	0	79
20 - 29 years	425	350	0	775
30 - 39 years	432	388	0	820
40 - 49 years	379	354	0	733
50 - 59 years	382	316	0	698
60 - 69 years	244	149	0	393
70 + years	144	29	0	173
Unknowna	22	12	0	34
Total	2,083	1,622	0	3,705b

Note:

1. There were 34 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 22 May 2021

Reaction	Number
Headache	1,389
Dizziness	1,088
Injection site pain	994
Nausea	905
Lethargy	849
Flu-like illness	600
Fever	520
Musculoskeletal pain	427
Feeling hot and cold	352
Numbness	236

Top 10 most frequently reported AEFIs, dose 1 only, up to and including 22 May 2021

Reaction	Number
Dizziness	657
Headache	592
Nausea	418
Injection site pain	416
Lethargy	305
Flu-like illness	207
Numbness	127
Syncope (fainting)	124
Musculoskeletal pain	119
Fever	116

Top 10 most frequently reported AEFIs, dose 2 only, up to and including 22 May 2021

Reaction	Number
Headache	797
Injection site pain	578
Lethargy	544
Nausea	487
Dizziness	431
Fever	404
Flu-like illnes	393
Musculoskeletal pain	308
Feeling hot and cold	264
Localised enlarged lymph node (swollen glands)	173

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 22 May 2021, a total of 4 deaths were reported to CARM after the administration of the Comirnaty vaccine. CARM and Medsafe have assessed each of these cases and found that the deaths were unlikely to be caused by the vaccine.

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 22 May 2021

AESI Category	AESI	Totala
Immune system disorders	Guillain-Barré Syndrome	0
	Thrombocytopenia	0
	Thrombosis with thrombocytopenia syndrome (TTS)	0
	Anaphylaxisb	12
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	<6
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	8
	Myelitis	0
Infections and musculoskeletal	Erythema multiforme	0
	Arthritis	0
	Herpes zoster	8

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