Published: 3 July 2023

Safety Information

Adverse reaction reporting in New Zealand – 2022

An assessment of the safety of a medicine cannot be made using only the information contained in this report. Medsafe advises patients NOT to make any changes to their medicine treatment based on information contained here. Changes to treatment should only be made following consultation with a health care professional.

This page provides information on suspected adverse reactions reported in New Zealand.

• New reporting format
• Number of reports
• Serious reports
• Reports by ethinicty
• Reports by age band
• Reports by substance
• Reported reactions
• Who is reporting
• Definitions
• More information

New reporting format

We have a new reporting format for 2022, so most of the tables and figures below also include data from 2018 to 2021. This new format means we can provide summary data by ethnicity and age group, and the most frequently reported substances and suspected adverse reactions.

As there is no universally agreed definition for Complementary and Alternative Medicines (CAMs), we are no longer providing summary data for CAMs. Instead, we are reporting on vaccines and non-vaccines (non-vaccines includes medicines, vitamins, dietary supplements and any other substance that is not a vaccine).

At the end of this report we have provided an Excel line listing of reports per year (2018 to 2022) for download. This line listing contains anonymised information from reports of suspected adverse reactions, including the CARM report ID, the age and sex of the patient, the reported reactions and the product (vaccine or non-vaccine) suspected to have caused the reactions. Please refer to the ‘READ ME’ sheet in the line listing for information about the data.

Number of reports

In 2022, there were 3,029 suspected adverse reaction reports received (Figure 1 and Table 1). There were 1,908 reports where a non-vaccine was suspected to have caused the reaction and 1,136 reports where a vaccine was suspected to be the cause (excluding COVID-19 vaccine reports). Because a single report can have more than one suspect non-vaccine or vaccine or a combination of both, the total number of reports may not always equal the sum of the non-vaccine plus vaccine reports.

Figure 1: Number of adverse reaction reports, 2018 to 2022

Notes:

• Non-vaccine includes medicines, vitamins, dietary supplements and any other substance that is not a vaccine.
• The vaccine data does not include reports for COVID-19 vaccines. See here for COVID-19 vaccine reports.
• A single report can contain a suspect non-vaccine and a suspect vaccine. Therefore, the total number of reports does not equal the sum of the non-vaccine + vaccine reports.

Serious reports

A serious adverse reaction is defined as any reaction that results in death or is life-threatening, causes or prolongs hospitalisation, results in persistent or significant disability/incapacity, is a congenital abnormality or is a medically important event.

Of all reports received in 2022, 23.7% were considered serious (Figure 2). Of the non-vaccine reports, 31.3% were serious. Of the vaccine reports, 11.0% were serious. These proportions have remained relatively stable since 2018, except for peak in non-vaccine serious reports in 2020. See Table 2 for the number and percentage of serious and non-serious reports by report type from 2018 to 2022.

Figure 2: Percentage of serious reports, by report type, 2018 to 2022

Table 2: Number (No.) and percentage (%) of non-serious and serious reports by report type, 2018 to 2022

Report type	2018		2019		2020		2021		2022
	No.	%	No.	%	No.	%	No.	%	No.	%
Non-serious
Non-vaccine	1,970	67.5%	1,856	67.8%	1,584	64.8%	1,469	69.2%	1,311	68.7%
Vaccine	1,312	89.9%	1,356	89.0%	1,119	88.5%	1,307	88.7%	1,011	89.0%
Total	3,269	74.9%	3,205	75.4%	2,702	72.9%	2,767	77.2%	2,311	76.3%
Serious
Non-vaccine	950	32.5%	883	32.2%	861	35.2%	655	30.8%	597	31.3%
Vaccine	147	10.1%	167	11.0%	145	11.5%	166	11.3%	125	11.0%
Total	1,095	25.1%	1,047	24.6%	1,004	27.1%	815	22.8%	718	23.7%

Notes:

• Non-vaccine includes medicines, vitamins, dietary supplements and any other substance that is not a vaccine.
• The vaccine data does not include reports for COVID-19 vaccines. See here for COVID-19 vaccine reports.
• A single report can contain a suspect non-vaccine and a suspect vaccine. Therefore, the total number of reports does not equal the sum of the non-vaccine + vaccine reports.

Reports by ethnicity

Table 3 shows reports received from 2018 to 2022, by ethnicity and report type.

Table 3: Number of reports by ethnicity and report type, 2018 to 2022

Ethnicity and Report type	2018	2019	2020	2021	2022
Māori
Non-vaccine	300	308	242	244	232
Vaccine	209	233	217	245	161
Total	509	539	458	488	392
Pacific peoples
Non-vaccine	124	109	132	122	104
Vaccine	50	77	52	57	42
Total	174	185	183	179	145
Asian
Non-vaccine	186	205	189	213	164
Vaccine	136	173	130	144	118
Total	321	377	319	351	281
European or Other
Non-vaccine	1,966	1,846	1,605	1,444	1,323
Vaccine	1,046	1,028	857	1,013	736
Total	2,999	2,869	2,461	2,449	2,051
Unknown
Non-vaccine	344	271	277	101	85
Vaccine	18	12	8	14	79
Total	361	282	285	115	160

Notes:

• Non-vaccine includes medicines, vitamins, dietary supplements and any other substance that is not a vaccine.
• The vaccine data does not include reports for COVID-19 vaccines. See here for COVID-19 vaccine reports.
• A single report can contain a suspect non-vaccine and a suspect vaccine. Therefore, the total number of reports does not always equal the sum of the non-vaccine + vaccine reports.

Reports by age band

Table 4: Number and type of reports by age band, 2018 to 2022

Age band and Report type	2018	2019	2020	2021	2022
0 - 9
Non-vaccine	182	145	128	94	89
Vaccine	622	733	609	709	540
Total	803	877	737	803	626
10 - 19
Non-vaccine	124	112	121	99	77
Vaccine	173	201	152	152	114
Total	297	313	273	251	191
20 - 29
Non-vaccine	279	249	204	174	172
Vaccine	92	111	74	72	70
Total	370	360	276	246	242
30 - 39
Non-vaccine	363	282	260	274	192
Vaccine	41	84	50	60	63
Total	403	364	310	332	254
40 - 49
Non-vaccine	421	364	329	260	230
Vaccine	60	92	58	55	70
Total	479	453	387	314	298
50 - 59
Non-vaccine	489	429	358	356	287
Vaccine	73	68	67	76	63
Total	559	497	425	430	348
60 - 69
Non-vaccine	479	474	451	371	351
Vaccine	193	120	130	164	109
Total	670	591	581	528	458
70 - 79
Non-vaccine	384	452	400	315	314
Vaccine	188	96	98	137	63
Total	567	547	498	451	374
80+
Non-vaccine	199	232	194	181	196
Vaccine	17	18	26	48	44
Total	216	250	219	227	238

Notes:

• Non-vaccine includes medicines, vitamins, dietary supplements and any other substance that is not a vaccine.
• The vaccine data does not include reports for COVID-19 vaccines. See here for COVID-19 vaccine reports.
• A single report can contain a suspect non-vaccine and a suspect vaccine. Therefore, the total number of reports does not always equal the sum of the non-vaccine + vaccine reports.

Figure 3 shows the proportion of reports by report type and age band for 2022. Younger age groups have the highest proportion of vaccine reports and the lowest proportion of non-vaccine reports. This likely reflects high vaccine use in these groups due to the recommended immunisation schedule, along with low non-vaccine use.

Figure 3: Proportion of reports by report type and age band, 2022

Reports by substance

Tables 5 to 7 show the most frequently reported substances for 2022. The Diphtheria + Pertussis + Poliomyelitis + Tetanus vaccine was the most frequently reported vaccine (245 reports) and Iohexol the most frequently reported non-vaccine (234 reports).

Table 5: Top 10 most frequently reported suspect substances (non-vaccines + vaccines), 2022

Substance	Type	No. reports
Diphtheria + Pertussis + Poliomyelitis + Tetanus vaccine	Vaccine	245
Iohexol	Non-vaccine	234
Influenza vaccine polyvalent	Vaccine	221
Nirmatrelvir + Ritonavir	Non-vaccine	119
Pneumococcal vaccines	Vaccine	114
Measles + Mumps + Rubella vaccine	Vaccine	109
Diphtheria + Pertussis + Tetanus vaccine	Vaccine	103
Clozapine	Non-vaccine	97
Diphtheria + Haemophilus influenzae type b + Hepatitis B + Pertussis + Poliomyelitis + Tetanus vaccine	Vaccine	77
Varicella vaccines	Vaccine	71

Notes:

• Because children receive a number of vaccines at the same time, it can be difficult to determine which vaccine is causing the reaction. This means that the number of reports for these vaccines may be high.
• Pneumococcal vaccines includes conjuate and polysaccharide vaccines.
• Varicella vaccines includes varicella and shingles vaccines.

Table 6: Top 10 most frequently reported suspect non-vaccines, 2022

Non-vaccine	No. reports
Iohexol	234
Nirmatrelvir + Ritonavir	119
Clozapine	97
Ferric carboxymaltose	58
Amoxicillin + Clavulanic acid	54
Flucloxacillin	51
Sulfamethoxazole + Trimethoprim	49
Amoxicillin	45
Ceftriaxone	31
Molnupiravir	30

Table 7: Top 10 most frequently reported vaccines, 2022

Vaccine	No. reports
Diphtheria + Pertussis + Poliomyelitis + Tetanus vaccine	245
Influenza vaccine polyvalent	221
Pneumococcal vaccines	114
Measles + Mumps + Rubella vaccine	109
Diphtheria + Pertussis + Tetanus vaccine	103
Diphtheria + Haemophilus influenzae type b + Hepatitis B + Pertussis + Poliomyelitis + Tetanus vaccine	77
Varicella vaccines	71
Human papillomavirus vaccine	66
Rotavirus vaccine	52
Haemophilus influenzae type b vaccine	43

Notes:

• Because children receive a number of vaccines at the same time, it can be difficult to determine which vaccine is causing the reaction. This means that the number of reports for these vaccines may be high.
• Pneumococcal vaccines includes conjuate and polysaccharide vaccines.
• Varicella vaccines includes varicella and shingles vaccines.

Reported reactions

Tables 8 to 10 show the most frequently reported adverse reactions. For all reports, injection site inflammation was the most frequently reported reaction (310 reports), followed by urticaria (235 reports). For non-vaccines, urticaria (201) and pruritus (159) were most frequently reported. For vaccines, injection site inflammation (310) and injection site pain (148) were the most frequently reported reactions.

Table 8: Top 10 most frequently reported adverse reactions (non-vaccines + vaccines), 2022

Reaction	No.
Injection site inflammation	310
Urticaria (raised, itchy rash)	235
Rash	182
Pruritus (itching)	180
Injection site pain	159
Nausea	159
Pyrexia (fever)	154
Rash pruritic (itchy rash)	119
Vomiting	119
Headache	109

Notes:

• Non-vaccine includes medicines, vitamins, dietary supplements and any other substance that is not a vaccine.
• The vaccine data does not include reports for COVID-19 vaccines. See here for COVID-19 vaccine reports.

Table 9: Top 10 most frequently reported adverse reactions for non-vaccines, 2022

Reaction	No.
Urticaria (raised, itchy rash)	201
Pruritus (itching)	159
Rash	135
Nausea	127
Rash pruritic (itchy rash)	100
Anaphylactic reaction	92
Vomiting	86
Dyspnoea (shortness of breath)	81
Angioedema (swelling under the skin)	76
Diarrhoea	67

Notes:

• Non-vaccine includes medicines, vitamins, dietary supplements and any other substance that is not a vaccine.

Table 10: Top 10 most frequently reported adverse reactions for vaccines, 2022

Reaction	No.
Injection site inflammation	310
Injection site pain	148
Pyrexia (fever)	100
Injection site erythema (redness)	67
Injection site pruritus (itchiness)	60
Pain in extremity (arm or leg pain)	55
Rash	49
Headache	44
Fatigue	37
Dizziness	36

Notes:

• The vaccine data does not include reports for COVID-19 vaccines. See here for COVID-19 vaccine reports.

Who is reporting?

Anyone can submit a report. Figure 4 and Table 11 show the number of reports by reporter type received during the last 5 years. In 2022, nurses submitted the most reports (1,096), followed by GPs (440) and hospital doctors (433).

Figure 4: Number of reports received by reporter type, 2018 to 2022

Definitions

Adverse reactions

An adverse drug reaction is an unexpected or unintended effect suspected to be caused by a medicine (including vaccines).

All medicines can cause side effects, the known side effects for a medicine are listed in the data sheets and consumer medicine information (CMI).

Search for a data sheet or CMI

Serious adverse reactions

A serious adverse reaction is any one of the following:

• a medically important event or reaction
• requires hospitalisation or prolong 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 adverse reaction but for the report to be serious for one person and non-serious for another person.

More information

Suspected Medicine Adverse Reaction Search (SMARS)
How Medsafe monitors medicine safety
How Medsafe monitors vaccine safety
Reporting side effects of medicines (PDF, 237 KB, 1 page)

Line listing

Download a line listing of suspected adverse reaction reports by year, 2018 to 2022 (Excel, 997 KB).

Please open the 'READ ME' sheet before reviewing the line listing data.