Published: 21 April 2021

COVID-19

Adverse events following immunisation with COVID-19 vaccines: Safety Report #3 – 20 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 number of AEFI reports, reports by age band and vaccine dose and the top 10 most frequently reported AEFIs by vaccine dose are provided below. Medsafe expects to provide some ethnicity information in the coming weeks.

AEFI reports received and vaccine doses administered, up to and including 20 March 2021

There were 83 new non-serious and 4 new serious cases reported since the last update. The 4 serious reports were allergic reactions and were managed appropriately.

AEFI reports received by age band and vaccine dose, up to and including 20 March 2021

Age	Dose 1	Dose 2	Dose unknown	Total
10 - 19 years	11	0	0	11
20 - 29 years	63	7	6	76
30 - 39 years	53	6	8	67
40 - 49 years	46	6	3	55
50 - 59 years	55	5	5	65
60 - 69 years	17	0	3	20
70 - 79 years	2	0	1	3
80+ years	0	0	0	0
Unknown	1	1	3	5
Total	248	25	29	302

Top 10 most frequently reported AEFIs, any dose^a, up to and including 20 March 2021

Reaction	Number
Dizziness	72
Headache	58
Nausea	53
Fever	22
Vasovagal/Syncopeb	22
Myalgiac	18
Fatigue	17
Arm pain	16
Faintness	13
Chills	12

Notes:

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

Top 10 most frequently reported AEFIs, dose 1 only, up to and including 20 March 2021

Reaction	Number
Dizziness	59
Nausea	40
Headache	36
Vasovagal/Syncopea	22
Faintness	11
Swelling	10
Feeling of warmth	8
Arm pain	7
Fever	7
Flu-like symptoms	7

Notes:

1. Vasovagal/Syncope: fainting

Top 10 most frequently reported AEFIs, dose 2 only, up to and including 20 March 2021

Reaction	Number
Headache	9
Fever	7
Myalgiaa	7
Dizziness	6
Nausea	6
Chills	5
Fatigue	5
Arm pain	4
Musculoskeletal pain	4
Flu-like symptoms	3

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