Published: 12 May 2021
Archived: 21 August 2024

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COVID-19 Archive

Adverse events following immunisation with COVID-19 vaccines: Safety Report #6 – 10 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 10 April 2021

254

New AEFI reports since last update

(241 new non-serious and 13 new serious)

1

New safety signal (potential safety issues) has been identified

117,746

Total doses administered

(cumulative)

885

Total AEFI reports that were non-serious

32

Total AEFI reports that were serious

917

Total AEFI reports that were received

(cumulative)


There were 241 new non-serious and 13 new serious cases reported this week. Eight of the serious reports were allergic reactions and were managed appropriately. Of the remaining 5 serious reports, there was 1 report each for: inflammatory muscle pain and stiffness; drug administration error; headache with collapse; blood clots; stroke.

New safety signal: blood clots

The reports of blood clots and stroke were reviewed by CARM and the COVID-19 Vaccine Independent Safety Monitoring Board (CV-ISMB) on 22 April 2021. None of these cases was considered to be related to vaccination. See Medsafe’s monitoring communication for more information.

AEFI reports received by prioritised ethnicity and vaccine dose, up to and including 10 April 2021

Ethnicitya Dose 1 Dose 2 Dose
unknownb
Total
Māori 50 18 0 68
Pacific Peoples 38 22 0 60
Asian 151 43 0 194
European/Other 425 151 0 576
Unknown 10 7 2 19
Total 674 241 2 917

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.
  2. There were 19 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 10 April 2021

Age Dose 1 Dose 2 Dose
unknowna
Total
10 - 19 years 24 2 0 26
20 - 29 years 167 57 0 224
30 - 39 years 154 56 0 210
40 - 49 years 122 61 0 183
50 - 59 years 125 48 0 173
60 - 69 years 62 16 0 78
70 - 79 years 15 0 0 15
80+ years 5 0 0 5
Unknown 0 1 2 3
Total 674 241 2 917

Notes:

  1. There were 3 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 10 April 2021

Reaction Number
Headache 237
Dizziness 220
Nausea 169
Injection site pain 125
Fever 73
Fu-like illness 63
Muscle pain 63
Lethargy 59
Syncopea 44
Joint pain 43

Note:

  1. Syncope: fainting

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

Reaction Number
Dizziness 174
Headache 137
Nausea 110
Injection site pain 86
Syncopea 35
Flu-like illness 32
Lethargy 30
Fever 29
Muscle pain 27
Vomiting 24

Note:

  1. Syncope: fainting

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

Reaction Number
Headache 100
Nausea 59
Dizziness 46
Fever 44
Injection site pain 39
Muscle pain 36
Musculoskeletal pain 32
Flu-like illness 31
Lethargy 29
Joint pain 28

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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