Published: 2 October 2025

Safety Information

Adverse reaction reporting in New Zealand – 2024

Medsafe advises people NOT to make any changes to their medicine based on information contained in this report. If you have questions or concerns about your medicine, please speak to a healthcare professional.

This page provides information on suspected adverse reactions reported to the New Zealand Pharmacovigilance Database in 2024.

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:

  1. 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:

  1. 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:

  1. 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.
  2. 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:

  1. 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:

  1. Comirnaty vaccine includes the two monovalent COVID-19 vaccines (tozinameran and raxtozinameran) and the bivalent (tozinameran + famtozinameran) COVID-19 vaccine.
  2. 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
  1. 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:

  1. Comirnaty vaccine includes the two monovalent COVID-19 vaccines (tozinameran and raxtozinameran) and the bivalent (tozinameran + famtozinameran) COVID-19 vaccine.
  2. 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:

  1. Non-vaccine includes medicines, vitamins, dietary supplements and any other substance that is not a vaccine.
  2. 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:

  1. Non-vaccine includes medicines, vitamins, dietary supplements and any other substance that is not a vaccine.
  2. 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.
  3. Of the 106 product substitution issue reports, 42 were associated with estradiol.
  4. 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:

  1. 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:

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