Published: 9 June 2021

COVID-19

Adverse events following immunisation with COVID-19 vaccines: Safety Report #10 – 8 May 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 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 8 May 2021

There were 539 non-serious and 12 serious reports this week. Four of the serious reports described allergic reactions. There was one report each for: chest discomfort, Bell’s Palsy, seizure, myocarditis, vertigo and hearing loss. Sadly, we are also reporting the deaths of two elderly individuals this week. Both deaths are considered by CARM, Medsafe and medical staff involved to be unrelated to the administration of Comirnaty but were reported through an abundance of caution.

There were also two reports of breastfed infants becoming unwell after their mother received the vaccine. One of the infants had an allergic reaction and the other infant had flu-like symptoms. Note that because these infants did not receive the vaccine, they are not included in the AEFI tables below.

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 5.

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: herpes zoster (shingles)

Cases of herpes zoster following COVID-19 vaccination have been reported in New Zealand and internationally. Thus far, 7 cases of herpes zoster have been detected in New Zealand. So far, a causal link has not been established. Medsafe will continue to monitor this signal through our usual safety monitoring processes.

Ongoing safety signal: myocarditis

Cases of myocarditis have been reported in the past, including one 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 8 May 2021

Ethnicitya	Dose 1	Dose 2	Dose unknownb	Total
Māori	116	59	0	175
Pacific Peoples	89	66	0	155
Asian	320	196	0	516
European/Other	1,066	665	0	1,731
Unknown	35	21	0	56
Total	1,626	1,005	0	2,631

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 56 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 8 May 2021

Age	Dose 1	Dose 2	Dose unknowna	Total
10 - 19 years	48	11	0	59
20 - 29 years	354	214	0	568
30 - 39 years	355	251	0	606
40 - 49 years	296	233	0	529
50 - 59 years	308	191	0	499
60 - 69 years	176	84	0	260
70 - 79 years	52	10	0	62
80+ years	22	4	0	26
Unknown	15	7	0	22
Total	1,626	1,005	0	2,631

Note:

1. There were 22 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 8 May 2021

Reaction	Number
Headache	936
Dizziness	770
Injection site pain	659
Nausea	616
Lethargy	523
Fever	425
Flu-like illness	381
Musculoskeletal pain	251
Feeling hot and cold	181
Muscle pain	159

Top 10 most frequently reported AEFIs, dose 1 only, up to and including 8 May 2021

Reaction	Number
Dizziness	521
Headache	460
Nausea	333
Injection site pain	322
Lethargy	217
Flu-like illness	155
Fever	137
Syncopea	104
Numbness	89
Musculoskeletal pain	82

Note:

1. Syncope: fainting

Top 10 most frequently reported AEFIs, dose 2 only, up to and including 8 May 2021

Reaction	Number
Headache	476
Injection site pain	337
Lethargy	306
Fever	288
Nausea	283
Dizziness	249
Flu-like illness	226
Musculoskeletal pain	209
Feeling hot and cold	130
Localised enlarged lymph nodea	98

Note:

1. Localised enlarged lymph node: swollen glands

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