Published: 26 May 2021
Archived: 21 August 2024

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COVID-19 Archive

Adverse events following immunisation with COVID-19 vaccines: Safety Report #8 – 24 April 2021

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 24 April 2021

422

New AEFI reports since last update

(403 new non-serious and 19 new serious)

1

New safety signal (potential safety issue) has been identified

224,032

Total doses administered

(cumulative)

1,610

Total AEFI reports that were non-serious

76

Total AEFI reports that were serious

1,686

Total AEFI reports that were received

(cumulative)


There were 403 non-serious and 19 serious reports this week. Twelve of the serious reports were for allergic reactions and 3 were for reactogenicity reactions (flu-like symptoms). The remaining serious reports were: myocarditis (1 report; see the New safety signal section below), stroke (2 reports), impaired consciousness (1 report).

Anaphylaxis

Of the 12 reports of allergic reactions this week, there were 3 reports where the reporter indicated suspected anaphylaxis. CARM assessed these cases against the Brighton Collaboration case definition for anaphylaxis. One case was possible Brighton anaphylaxis level 3, one case was possible Brighton anaphylaxis level 2 and the last case was 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: myocarditis

There was one serious report of myocarditis this week. Medsafe is currently reviewing this signal and we will provide further information once the review is completed.

AEFI reports received by prioritised ethnicity and vaccine dose, up to and including 24 April 2021

Ethnicitya Dose 1 Dose 2 Dose
unknownb
Total
Māori 83 31 0 114
Pacific Peoples 72 41 0 113
Asian 244 92 0 336
European/Other 751 337 0 1,088
Unknown 16 17 2 35
Total 1,166 518 2 1,686

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 35 AEFI reports where the person’s ethnicity was not reported, including 2 reports where both the ethnicity and vaccine dose number were 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.

AEFI reports received by age band and vaccine dose, up to and including 24 April 2021

Age Dose 1 Dose 2 Dose
unknowna
Total
10 - 19 years 37 4 0 41
20 - 29 years 268 125 0 393
30 - 39 years 262 123 0 385
40 - 49 years 217 118 0 335
50 - 59 years 222 103 0 325
60 - 69 years 118 39 0 157
70 - 79 years 30 3 0 33
80+ years 12 1 0 13
Unknown 0 2 2 4
Total 1,166 518 2 1,686

Note:

  1. There were 4 AEFI reports where the person’s age was not reported, including 2 reports where both the age and vaccine dose number were 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.

Top 10 most frequently reported AEFIs, any dose, up to and including 24 April 2021

Reaction Number
Headache 508
Dizziness 435
Nausea 340
Injection site pain 314
Lethargy 238
Flu-like illness 174
Fever 158
Muscle pain 140
Musculoskeletal pain 97
Joint pain 86

Top 10 most frequently reported AEFIs, dose 1 only, up to and including 24 April 2021

Reaction Number
Dizziness 343
Headache 297
Nausea 211
Injection site pain 184
Lethargy 114
Flu-like illness 80
Fever 65
Muscle pain 57
Syncopea 57
Numbness 43

Note:

  1. Syncope: fainting

Top 10 most frequently reported AEFIs, dose 2 only, up to and including 24 April 2021

Reaction Number
Headache 211
Injection site pain 130
Nausea 129
Lethargy 124
Flu-like illness 94
Fever 93
Dizziness 92
Muscle pain 83
Musculoskeletal pain 68
Joint pain 54


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

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