Published: 23 June 2021
Archived: 21 August 2024

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COVID-19 Archive

Adverse events following immunisation with COVID-19 vaccines: Safety Report #12 – 22 May 2021

Introduction

This page provides information on the number of adverse events following immunisation (AEFI) reports received for COVID-19 vaccines.

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.

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.

Medsafe and CARM thank everyone who has contributed to the monitoring of COVID-19 vaccines. Please continue to report any adverse events following immunisation.

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 22 May 2021

493

New AEFI reports since last update

(469 new non-serious and 24 new serious)

0

New safety signals (potential safety issue) have been identified

530,855

Total doses administered

(cumulative)

3,558

Total AEFI reports that were non-serious

149

Total AEFI reports that were serious

3,707

Total AEFI reports that were received

(cumulative)


There were 469 non-serious and 24 serious reports this week. Sadly, one of these serious reports reported on the death of one person. The death is considered by CARM, Medsafe and medical staff involved to be unrelated to the vaccine but was reported through an abundance of caution.

Furthermore, five of the serious reports were described as allergic reactions, 4 reports were for reactogenicity reactions (flu-like symptoms) and 3 reports were for pulmonary embolism. Of the remaining 12 reports, there was one report each for: stroke, palpitations, myopericarditis, seizure, taste perversion, haemorrhage, persisting fatigue, facial palsy, eye infection, deep vein thrombosis, impaired consciousness and tachycardia.

Anaphylaxis

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.

Of the 5 serious reports of allergic reactions this week, there was 1 report where the reporter indicated suspected anaphylaxis. CARM assessed this case against the Brighton Collaboration case definition for anaphylaxis. This case was a possible Brighton anaphylaxis level 1.

Ongoing safety signal: myocarditis

Medsafe continues to investigate this safety signal. We have published a monitoring communication to encourage further reporting of cases of myocarditis in patients who have been vaccinated with Comirnaty.

AEFI reports received by prioritised ethnicity and vaccine dose, up to and including 22 May 2021

Ethnicitya Dose 1 Dose 2 Dose
unknown
Total
Māori 146 113 0 259
Pacific Peoples 120 91 0 211
Asian 393 279 0 672
European/Other 1,381 1,109 0 2,490
Unknownb 43 30 0 73
Total 2,083 1,622 0 3,705c

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 73 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.
  3. The total is different from the cumulative total above because it excludes 2 AEFI reports received for infants who did not receive the vaccine (see safety report 10).

AEFI reports received by age band and vaccine dose, up to and including 22 May 2021

Age Dose 1 Dose 2 Dose
unknowna
Total
10 - 19 years 55 24 0 79
20 - 29 years 425 350 0 775
30 - 39 years 432 388 0 820
40 - 49 years 379 354 0 733
50 - 59 years 382 316 0 698
60 - 69 years 244 149 0 393
70 + years 144 29 0 173
Unknowna 22 12 0 34
Total 2,083 1,622 0 3,705b

Note:

  1. There were 34 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.
  2. The total is different from the cumulative total above because it excludes 2 AEFI reports received for infants who did not receive the vaccine (see safety report 10).

Top 10 most frequently reported AEFIs, any dose, up to and including 22 May 2021

Reaction Number
Headache 1,389
Dizziness 1,088
Injection site pain 994
Nausea 905
Lethargy 849
Flu-like illness 600
Fever 520
Musculoskeletal pain 427
Feeling hot and cold 352
Numbness 236

Top 10 most frequently reported AEFIs, dose 1 only, up to and including 22 May 2021

Reaction Number
Dizziness 657
Headache 592
Nausea 418
Injection site pain 416
Lethargy 305
Flu-like illness 207
Numbness 127
Syncope (fainting) 124
Musculoskeletal pain 119
Fever 116

Top 10 most frequently reported AEFIs, dose 2 only, up to and including 22 May 2021

Reaction Number
Headache 797
Injection site pain 578
Lethargy 544
Nausea 487
Dizziness 431
Fever 404
Flu-like illnes 393
Musculoskeletal pain 308
Feeling hot and cold 264
Localised enlarged lymph node (swollen glands) 173


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.

Summary of reported deaths

Up to and including 22 May 2021, a total of 4 deaths were reported to CARM after the administration of the Comirnaty vaccine. CARM and Medsafe have assessed each of these cases and found that the deaths were unlikely to be caused by the vaccine.

By chance, some people will experience new illnesses or die from a pre-existing condition shortly after vaccination, especially if they are elderly. Therefore, part of our review process includes comparing natural death rates to observed death rates following vaccination, to determine if there are any specific trends or patterns that might indicate a vaccine safety concern. There are currently no indications to suggest that the vaccine caused the deaths.

To date, the observed number of deaths reported after vaccination is actually less than the expected number of deaths.

Adverse events of special interest

Adverse events of special interest (AESI) are pre-specified medically significant events that have the potential to be causally associated with the vaccine and must be carefully monitored. AESI can be serious or non-serious and can include:

  • Events of interest due to their association with COVID-19 infection.
  • Events of interest for vaccines in general (e.g. to the specific vaccine type or adjuvants).

The list of AESIs below takes into consideration the lists of AESIs from expert groups such as the Brighton Collaboration, manufacturers and other regulatory authorities. The AESI list changes based on the evolving safety profile of vaccines. It is important to note that although these adverse events may occur after being vaccinated with a COVID-19 vaccine in New Zealand, they are rare and may not necessarily be related to the vaccine. Medsafe and CARM review the reports to determine whether the vaccine may have played a role in the occurrence of these events.

Adverse events of special interest (AESI) up to and including 22 May 2021

AESI Category AESI Totala
Immune system disorders Guillain-Barré Syndrome 0
Thrombocytopenia 0
Thrombosis with thrombocytopenia syndrome (TTS) 0
Anaphylaxisb 12
Cardiovascular system Myocardial infarction (heart attack) 0
Myocarditis/pericarditis <6
Blood and lymphatic system Thrombosis <6
Embolism <6
Deep vein thrombosis (DVT) <6
Vasculitis 0
Haemorrhage <6
Hepato-gastrointestinal and renal system Acute kidney injury 0
Acute liver injury 0
Nervous system Aseptic meningitis 0
Encephalitis 0
Stroke <6
Bell's Palsy/facial paralysis 8
Myelitis 0
Infections and musculoskeletal Erythema multiforme 0
Arthritis 0
Herpes zoster 8
  1. Includes all reports, both serious and non-serious. Counts below 6 are reported as <6 for privacy reasons.
  2. Includes reports meeting levels 1-3 of the Brighton Collaboration case definition.

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.
Adverse events of special interest (AESI)
An AESI is a pre-specified medically significant event that has the potential to be causally associated with the vaccine product based on past experience, the technology used to make the vaccine or the infection the vaccine is used to protect against. AESIs need to be carefully monitored and any potential association to vaccination confirmed by further analysis and studies.
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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