Published: 2 October 2025
Safety Information
Adverse reaction reporting in New Zealand – 2024
This page provides information on suspected adverse reactions reported to the New Zealand Pharmacovigilance Database in 2024.
- Extract date
- Number of reports
- Serious reports
- Reports by ethnicity and age
- Reports by substance
- Reported reactions
- Who is reporting?
- Definitions
- More information
Extract date
The data below was extracted from the New Zealand Pharmacovigilance Database on 22 August 2025. Please note that adverse reaction data is subject to change due to receipt of additional information.
Number of reports
There were 4,585 suspected adverse reaction reports received in 2024 (Table 1). Of these, 3,016 reports were for a non-vaccine and 1,569 were for a vaccine.
Table 1: Number (No.) of adverse reaction reports by report type, 2024
Report type | No. |
---|---|
Non-vaccinea | 3,016 |
Vaccine | 1,569 |
Total | 4,585 |
Notes:
- Non-vaccine includes medicines, vitamins, dietary supplements and any other substance that is not a vaccine.
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.
A report will be coded as serious in the database if the reporter considers that one or more of the suspected reaction(s) were serious. We may also upgrade a non-serious report to serious if the reported information indicates that one of the seriousness criteria has been met. However, we don’t downgrade a serious report to non-serious.
Of the 4,585 reports received, 2,900 (63.2%) were coded as serious in the database (Table 2).
Table 2: Number (No.) and percentage (%) of non-serious and serious reports by report type, 2024
Seriousness | Non-vaccinea | Vaccine | Total | |||
---|---|---|---|---|---|---|
No. | % | No. | % | No. | % | |
Non-serious | 815 | 27.0% | 870 | 55.4% | 1,685 | 36.8% |
Serious | 2,201 | 73.0% | 699 | 44.6% | 2,900 | 63.2% |
Total | 3,016 | 100.0% | 1,569 | 100.0% | 4,585 | 100.0% |
Notes:
- Non-vaccine includes medicines, vitamins, dietary supplements and any other substance that is not a vaccine.
Reports by ethnicity and age
Tables 3 and 4 show reports by ethnicity and age, respectively.
Table 3: Number of reports by ethnicity and report type, 2024
Ethnicitya | Non-vaccineb | Vaccine | Total |
---|---|---|---|
Māori | 121 | 102 | 223 |
Pacific peoples | 84 | 24 | 108 |
Asian | 120 | 123 | 243 |
European or Other | 983 | 904 | 1,887 |
Unknown or not reported | 1,708 | 416 | 2,124 |
Total | 3,016 | 1,569 | 4,585 |
Notes:
- Ethnicity is based on prioritised ethnicity, which means each person is only counted against a single ethnicity category. When a person has multiple ethnicities recorded, then the prioritised ethnicity is ranked in the order of 1) Māori 2) Pacific Peoples 3) Asian 4) Other. For example, if a person is recorded as their ethnicities being both Māori and Pacific Peoples, their prioritised ethnicity will be Māori, ie, they will not be counted in the Pacific Peoples group.
- Non-vaccine includes medicines, vitamins, dietary supplements and any other substance that is not a vaccine.
Table 4: Number of reports by age band and report type, 2024
Age band | Non-vaccinea | Vaccine | Total |
---|---|---|---|
0–9 years | 86 | 523 | 609 |
10–19 years | 96 | 112 | 208 |
20–29 years | 168 | 50 | 218 |
30–39 years | 270 | 86 | 356 |
40–49 years | 261 | 82 | 343 |
50–59 years | 391 | 114 | 505 |
60–69 years | 431 | 261 | 692 |
70–79 years | 384 | 132 | 516 |
80+ years | 196 | 41 | 237 |
Unknown | 733 | 168 | 901 |
Total | 3,016 | 1,569 | 4,585 |
Notes:
- Non-vaccine includes medicines, vitamins, dietary supplements and any other substance that is not a vaccine.
Figure 1 shows the proportion of reports by report type and age band for 2024.
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.
Of the adult age groups, the 60–69 years age group had the highest proportion of vaccine reports. Again, this likely reflects the recommended immunisation schedule for this age group, with shingles vaccine recommended at age 65 years and influenza vaccine recommended from age 65 years.
Figure 1: Proportion of reports by report type and age band (years), 2024
Reports by substance
Tables 5 to 7 show the most frequently reported substances for 2024.
The Comirnaty COVID-19 vaccine was the most frequently reported vaccine (409 reports) and iohexol the most frequently reported non-vaccine substance (331 reports).
Table 5: Top 10 most frequently reported suspect substances, all reports (non-vaccines + vaccines), 2024
Substance | Type | No. reports |
---|---|---|
Comirnaty vaccinea | Vaccine | 409 |
Iohexol | Non-vaccine | 331 |
Meningococcal B vaccine | Vaccine | 241 |
Diphtheria + Tetanus + Pertussis + Polio vaccine | Vaccine | 204 |
Clozapine | Non-vaccine | 193 |
Influenza vaccine polyvalent | Vaccine | 189 |
Shingles (varicella zoster) vaccine | Vaccine | 181 |
Diphtheria + Tetanus + Pertussis vaccine | Vaccine | 135 |
Pneumococcal conjugate vaccineb | Vaccine | 116 |
Diphtheria + Tetanus+ Pertussis + Poliomyelitis + Hepatitis B + Haemophilus influenzae type b vaccine | Vaccine | 81 |
Notes:
- Comirnaty vaccine includes the two monovalent COVID-19 vaccines (tozinameran and raxtozinameran) and the bivalent (tozinameran + famtozinameran) COVID-19 vaccine.
- Pneumococcal conjugate vaccine includes PCV13 (Prevenar 13) and PCV10 (Synflorix) vaccines.
Table 6: Most frequently reported suspect non-vaccine substances, 2024
Non-vaccinea substance | No. |
---|---|
Iohexol | 331 |
Clozapine | 193 |
Cefazolin | 73 |
Estradiol | 73 |
Amoxicillin | 61 |
Empagliflozin | 57 |
Lenalidomide | 57 |
Ferric carboxymaltose | 54 |
Pembrolizumab | 54 |
Amoxicillin + clavulanic acid | 52 |
Flucloxacillin | 52 |
- Non-vaccine includes medicines, vitamins, dietary supplements and any other substance that is not a vaccine.
Table 7: Top 10 most frequently reported vaccines, 2024
Vaccine | No. |
---|---|
Comirnaty vaccinea | 409 |
Meningococcal B vaccine | 241 |
Diphtheria + Tetanus + Pertussis + Polio vaccine | 204 |
Influenza vaccine polyvalent | 189 |
Shingles (varicella zoster) vaccine | 181 |
Diphtheria + Tetanus + Pertussis vaccine | 135 |
Pneumococcal conjugate vaccineb | 116 |
Diphtheria + Tetanus+ Pertussis + Poliomyelitis + Hepatitis B + Haemophilus influenzae type b vaccine | 81 |
Measles + Mumps + Rubella vaccine | 52 |
Rotavirus vaccine | 50 |
Notes:
- Comirnaty vaccine includes the two monovalent COVID-19 vaccines (tozinameran and raxtozinameran) and the bivalent (tozinameran + famtozinameran) COVID-19 vaccine.
- Pneumococcal conjugate vaccine includes PCV13 (Prevenar 13) and PCV10 (Synflorix) vaccines.
Reported reactions
Tables 8 to 10 show the most frequently reported adverse reactions.
- For all reports (Table 8), urticaria (raised, itchy rash) was the most frequently reported reaction (366 reports), followed by pruritus (itching; 286 reports).
- For non-vaccines (Table 9), urticaria (305) and pruritus (245) were most frequently reported.
- For vaccines (Table 10), injection site erythema (redness; 137) and vaccination site reaction (129) were the most frequently reported reactions.
Table 8: Top 10 most frequently reported adverse reactions, all reports (non-vaccinesa + vaccines), 2024
Reaction | No. |
---|---|
Urticaria (raised, itchy rash) | 366 |
Pruritis (itching) | 286 |
Rash | 267 |
Anaphylactic reactionb | 245 |
Nausea | 224 |
Headache | 205 |
Fatigue | 167 |
Vomiting | 166 |
Dizziness | 162 |
Pyrexia (fever) | 162 |
Notes:
- Non-vaccine includes medicines, vitamins, dietary supplements and any other substance that is not a vaccine.
- Most of the anaphylactic reaction reports were associated with antibiotics, muscle relaxants and contrast agents. Anaphylactic reactions are known to occur with these medicines. They were reported by allergy clinics so that a medical warning can be added for the patient.
Table 9: Top 10 most frequently reported adverse reactions for non-vaccinea substances, 2024
Reaction | No. |
---|---|
Urticaria (raised, itchy rash) | 305 |
Pruritus (itching) | 245 |
Anaphylactic reactionb | 232 |
Rash | 213 |
Nausea | 134 |
Dyspnoea (shortness of breath) | 110 |
Product substitution issuec | 106 |
Drug ineffectived | 94 |
Vomiting | 89 |
Headache | 83 |
Notes:
- Non-vaccine includes medicines, vitamins, dietary supplements and any other substance that is not a vaccine.
- Most of the anaphylactic reaction reports were associated with antibiotics, muscle relaxants and contrast agents. Anaphylactic reactions are known to occur with these medicines. They were reported by allergy clinics so that a medical warning can be added for the patient.
- Of the 106 product substitution issue reports, 42 were associated with estradiol.
- Of the 94 drug ineffective reports, 38 were associated with estradiol.
Table 10: Top 10 most frequently reported adverse reactions for vaccines, 2024
Reaction | No. |
---|---|
Injection site erythema (redness) | 137 |
Vaccination site reaction | 129 |
Injection site reaction | 125 |
Headache | 123 |
Pyrexia (fever) | 113 |
Fatigue | 105 |
Injection site swelling | 94 |
Nausea | 90 |
Dizziness | 85 |
Vomiting | 77 |
Who is reporting?
Anyone can submit a report. Table 11 shows the number of reports by reporter type received in 2024. Nurses (1,161) and consumers (883) submitted the most reports.
Note that pharmaceutical companies receive reports from a variety of reporters (eg, nurses, consumers, GPs) and then submit the reports to the New Zealand Pharmacovigilance Database. We code these reports as per the original reporter, not as the pharmaceutical company.
Table 11: Number of reports received by reporter type, 2024
Reporter | No. |
---|---|
Nurse | 1,161 |
Publica | 883 |
Hospital doctor/physician | 773 |
Other healthcare professional | 696 |
Pharmacist | 649 |
General practitioner | 423 |
Total | 4,585 |
Note:
- Public includes consumers and non-healthcare professionals.
Definitions
- Adverse reactions
- An adverse drug reaction is an unexpected or unintended effect suspected to be caused by a medicine (including vaccines).
- Serious adverse reactions
- A serious adverse reaction is one where the
reporter considered that the reaction:
- was medically important
- required hospitalisation or prolonged an existing hospitalisation
- caused persistent or significant disability or incapacity
- was life threatening
- caused a congenital anomaly/birth defect
- resulted in death.
A report may be upgraded to serious if the reported information indicates that one of the seriousness criteria has been met, but we don’t downgrade a serious report to non-serious.
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
All medicines can cause side effects, the known side effects for a medicine are listed in the data sheets and consumer medicine information (CMI).
See also: