Published: 28 April 2021
Archived: 21 August 2024

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COVID-19 Archive

Adverse events following immunisation with COVID-19 vaccines: Safety Report #4 – 27 March 2021

• Introduction
• Adverse events following immunisation (AEFI) reported
• 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.

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 27 March 2021

There were 151 new non-serious and 4 new serious cases reported since the last update. Two of the serious reports were allergic reactions and were managed appropriately. One was a report of reactogenicity type reactions (flu-like symptoms). The final serious report was for a seizure-type event.

AEFI reports received by prioritised ethnicity and vaccine dose, up to and including 27 March 2021

Ethnicitya	Dose 1	Dose 2	Dose unknown	Total
Māori	16	0	1	17
Pacific Peoples	18	6	0	24
Asian	73	15	3	91
European/Other	173	24	6	203
Unknown	41	58	23	122
Total	321	103	33	457

Note:

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.

AEFI reports received by age band and vaccine dose, up to and including 27 March 2021

Age	Dose 1	Dose 2	Dose unknown	Total
10 - 19 years	13	1	0	14
20 - 29 years	88	22	6	116
30 - 39 years	70	24	8	102
40 - 49 years	58	26	4	88
50 - 59 years	64	21	5	90
60 - 69 years	23	2	5	30
70 - 79 years	2	0	1	3
80+ years	0	0	0	0
Unknown	3	7	4	14
Total	321	103	33	457

Top 10 most frequently reported AEFIs, any dose^a, up to and including 27 March 2021

Reaction	Number
Dizziness	120
Headache	111
Nausea	84
Fatigue	52
Fever	49
Myalgiab	37
Chills	33
Arm pain	31
Flu-like symptoms	31
Vasovagal/Syncopec	25

Notes:

1. Includes AEFIs reported for dose 1, dose 2 or dose unknown
2. Myalgia: muscle pain
3. Vasovagal/Syncope: fainting

Top 10 most frequently reported AEFIs, dose 1 only, up to and including 27 March 2021

Reaction	Number
Dizziness	91
Headache	57
Nausea	52
Vasovagal/Syncopea	25
Faintness	20
Fatigue	19
Fever	14
Flu-like symptoms	12
Myalgiab	11
Swelling	11

Notes:

1. Vasovagal/Syncope: fainting
2. Myalgia: muscle pain

Top 10 most frequently reported AEFIs, dose 2 only, up to and including 27 March 2021

Reaction	Number
Headache	40
Fever	27
Fatigue	24
Nausea	24
Chills	23
Dizziness	21
Myalgiaa	21
Musculoskeletal pain	19
Flu-like symptoms	17
Arm pain	16

Notes:

1. Myalgia: muscle pain

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.

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

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.

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