Published: 16 June 2021

COVID-19

Adverse events following immunisation with COVID-19 vaccines: Safety Report #11 – 15 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 15 May 2021

There were 557 non-serious and 24 serious reports this week. Nine of the serious reports described as allergic reactions and 2 were for reactogenicity (flu-like symptoms). The remaining reports were for: thrombosis (3 cases), reduced vision (2 cases), kidney injury (1 case), blood in urine (1 case), seizure (2 cases), polyarthritis (1 case) and facial paralysis (2 cases).

Sadly, we are also reporting the death of one elderly individual this week. The death is considered by CARM, Medsafe and medical staff involved to be unrelated to the administration of Comirnaty but was reported through an abundance of caution.

Anaphylaxis

Of the 9 reports of allergic reactions this week, there were 6 reports where the reporter indicated suspected anaphylaxis. CARM assessed these cases against the Brighton Collaboration case definition for anaphylaxis.

• Level 1 - two cases
• Level 2 - two cases
• Level 3 - no cases
• Level 4 - one case
• Level 5 - one case

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: 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, a causal link has not been established. Medsafe will continue to monitor this signal through our usual safety monitoring processes.

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 15 May 2021

Ethnicitya	Dose 1	Dose 2	Dose unknown	Total
Māori	127	90	0	217
Pacific Peoples	103	81	0	184
Asian	364	242	0	606
European/Other	1,242	898	0	2,140
Unknownb	40	25	0	65
Total	1,876	1,336	0	3,212c

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 65 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 15 May 2021

Age	Dose 1	Dose 2	Dose unknowna	Total
10 - 19 years	50	20	0	70
20 - 29 years	392	286	0	678
30 - 39 years	398	325	0	723
40 - 49 years	341	299	0	640
50 - 59 years	354	253	0	607
60 - 69 years	218	120	0	338
70 + years	104	24	0	128
Unknown	19	9	0	28
Total	1,876	1,336	0	3,212b

Note:

1. There were 28 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 15 May 2021

Reaction	Number
Headache	1,182
Dizziness	933
Injection site pain	839
Nausea	782
Lethargy	705
Flu-like illness	506
Fever	386
Musculoskeletal pain	366
Feeling hot and cold	294
Numbness	201

Top 10 most frequently reported AEFIs, dose 1 only, up to and including 15 May 2021

Reaction	Number
Dizziness	588
Headache	531
Nausea	375
Injection site pain	373
Lethargy	266
Flu-like illness	186
Syncopea	118
Numbness	114
Musculoskeletal pain	104
Fever	88

Note:

1. Syncope: fainting

Top 10 most frequently reported AEFIs, dose 2 only, up to and including 15 May 2021

Reaction	Number
Headache	651
Injection site pain	466
Lethargy	439
Nausea	407
Dizziness	345
Flu-like illness	320
Fever	298
Musculoskeletal pain	262
Feeling hot and cold	222
Localised enlarged lymph nodea	137

Note:

1. Localised enlarged lymph node: swollen glands

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 15 May 2021

AESI Category	AESI	Total1
Immune system disorders	Guillain-Barré Syndrome	0
	Thrombocytopenia	0
	Thrombosis with thrombocytopenia syndrome (TTS)	0
	Anaphylaxis2	11
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	7
	Myelitis	0
Infections and musculoskeletal	Erythema multiforme	0
	Arthritis	0
	Herpes zoster	7
All AESI categories	Total	37

1. Counts below 6 are reported as <6 for privacy reasons.
2. Includes reports meeting levels 1-3 of the Brighton Collaboration case definition.

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