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COVID-19 Archive

Adverse events following immunisation with COVID-19 vaccines: Safety Report #2 – 13 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 the top 10 most frequently reported AEFIs 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 13 March 2021

New AEFI reports since last update

(65 new non-serious and 3 new serious)

No safety signals (potential safety issues) have been identified

22,588

Total doses administered

(cumulative)

209

Total AEFI reports that were non-serious

Total AEFI reports that were serious

215

Total AEFI reports that were received

(cumulative)

There were 65 new non-serious and 3 new serious cases reported since the last update. Two of the three serious cases were allergic reactions and were managed appropriately. The third serious case was a reactogenicity reaction, where the patient experienced flu-like symptoms.

AEFI reports received by age band, up to and including 13 March 2021

Age	Number
10 - 19 years	6
20 - 29 years	54
30 - 39 years	46
40 - 49 years	41
50 - 59 years	51
60 - 69 years	13
70 - 79 years	1
80+ years	0
Unknown	3
Total	215

Top 10 most frequently reported AEFIs, up to and including 13 March 2021

Reaction	Number
Dizziness	49
Headache	37
Nausea	36
Vasovagal/Syncope^a	22
Faintness	9
Erythema^b	8
Fatigue	8
Fever	8
Injection site pain	8
Swelling	8

Notes:

Vasovagal/Syncope: fainting
Erythema: redness

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.