Published: 26 May 2021

COVID-19

Adverse events following immunisation with COVID-19 vaccines: Safety Report #9 – 1 May 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 1 May 2021

379

New AEFI reports since last update

(366 new non-serious and 13 new serious)

0

New safety signals (potential safety issue) have been identified

281,005

Total doses administered

(cumulative)

1,991

Total AEFI reports that were non-serious

90

Total AEFI reports that were serious

2,081

Total AEFI reports that were received

(cumulative)


There were 366 non-serious and 13 serious reports this week. Of the serious reports, four were for allergic reactions, two of which were reported as anaphylaxis (see below). The remaining serious reports were for: transient ischemic attack (stroke-like symptoms), stroke, seizure, Bell’s Palsy, hearing loss, hyperglycaemia, impaired consciousness and spontaneous bleeding from the groin.

Anaphylaxis

Of the 4 reports of allergic reactions this week, there were 2 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 2 and one 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.

Ongoing safety signal: myocarditis

There was one serious report of myocarditis last 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 1 May 2021

Ethnicitya Dose 1 Dose 2 Dose
unknownb
Total
Māori 99 43 0 142
Pacific Peoples 83 47 0 130
Asian 274 143 0 417
European/Other 896 451 0 1,347
Unknown 29 16 0 45
Total 1,381 700 0 2,081

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 45 AEFI reports where the person’s ethnicity was 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 1 May 2021

Age Dose 1 Dose 2 Dose
unknowna
Total
10 - 19 years 44 6 0 50
20 - 29 years 309 153 0 462
30 - 39 years 298 169 0 467
40 - 49 years 254 165 0 419
50 - 59 years 267 133 0 400
60 - 69 years 143 58 0 201
70 - 79 years 38 7 0 45
80+ years 9 3 0 12
Unknown 12 6 0 18
Total 1,381 700 0 2,081

Note:

  1. There were 18 AEFI reports where the person’s age was 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 1 May 2021

Reaction Number
Headache 694
Dizziness 589
Nausea 448
Injection site pain 475
Lethargy 370
Flu-like illness 267
Fever 183
Musculoskeletal pain 166
Muscle pain 159
Syncopea 115

Note:

  1. Syncope: fainting

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

Reaction Number
Dizziness 439
Headache 385
Nausea 273
Injection site pain 270
Lethargy 180
Flu-like illness 129
Syncopea 90
Fever 75
Numbness 73
Muscle pain 69

Note:

  1. Syncope: fainting

Top 10 most frequently reported AEFIs, dose 2 only, up to and including 1 May 2021

Reaction Number
Headache 309
Injection site pain 208
Lethargy 190
Nausea 175
Dizziness 150
Flu-like illness 138
Fever 108
Musculoskeletal pain 106
Muscle pain 90
Joint pain 60


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

Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /