Published: 15 January 2025
Safety Information
Adverse reaction reporting in New Zealand – 2023
This page provides information on suspected adverse reactions reported to the New Zealand Pharmacovigilance Database in 2023.
- New database
- Number of reports
- Serious reports
- Reports by ethnicity and age
- Reports by substance
- Reported reactions
- Who is reporting?
- Definitions
- More information
New database
In September 2023, the collection, processing (coding) and storage of adverse reaction reports moved from the Centre for Adverse Reactions Monitoring (CARM) to a new database run by Medsafe (the New Zealand Pharmacovigilance Database). The CARM experts now focus on the valuable role of medical assessment of non-routine reports.
The change to the new database means that the 2023 data cannot be directly compared to previous years. And unlike the 2022 and 2021 data, the 2023 data includes COVID-19 vaccines.
The data below was extracted from the New Zealand Pharmacovigilance Database on 3 December 2024. The data was correct at the time of extraction but may change over time due to receipt of additional information.
Number of reports
There were 5,515 suspected adverse reaction reports received in 2023 (Table 1). Of these, 3,186 reports were for a non-vaccine and 2,329 were for a vaccine.
Table 1: Number (No.) of adverse reaction reports by report type, 2023
| Report type | No. |
|---|---|
| Non-vaccine | 3,186 |
| Vaccine | 2,329 |
| Total | 4,364 |
Notes:
- Non-vaccine includes medicines, vitamins, dietary supplements and any other substance that is not a vaccine.
- The vaccine reports include COVID-19 vaccines.
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. Medsafe or CARM may also upgrade a report to serious if we disagree with the reporter, but we don’t downgrade a serious report to non-serious.
Of the 5,515 reports received, 3,547 (64.3%) were coded as serious in the database (Table 2).
Table 2: Number (No.) and percentage (%) of non-serious and serious reports by report type, 2023
| Seriousness | Non-vaccine | Vaccine | Total | |||
|---|---|---|---|---|---|---|
| No. | % | No. | % | No. | % | |
| Non-serious | 533 | 16.7% | 1,435 | 61.6% | 1,968 | 35.7% |
| Serious | 2,653 | 83.3% | 894 | 38.4% | 3,547 | 64.3% |
| Total | 3,186 | 100.0% | 2,329 | 100.0% | 5,515 | 100.0% |
Notes:
- Non-vaccine includes medicines, vitamins, dietary supplements and any other substance that is not a vaccine.
- The vaccine reports include COVID-19 vaccines.
Reports by ethnicity and age
Reports by ethnicity and age are shown in Tables 3 and 4, respectively.
Table 3: Number of reports by ethnicity and report type, 2023
| Ethnicity | Non-vaccine | Vaccine | Total |
|---|---|---|---|
| Māori | 190 | 166 | 356 |
| Pacific peoples | 108 | 41 | 149 |
| Asian | 167 | 177 | 344 |
| European or Other | 1,243 | 1,468 | 2,711 |
| Unknown or not reported | 1,478 | 477 | 1,955 |
| Total | 3,186 | 2,329 | 5,515 |
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.
- The vaccine reports include COVID-19 vaccines.
Table 4: Number of reports by age band and report type, 2023
| Age band | Non-vaccine | Vaccine | Total |
|---|---|---|---|
| 0–9 years | 263 | 687 | 950 |
| 10–19 years | 126 | 120 | 246 |
| 20–29 years | 207 | 69 | 276 |
| 30–39 years | 285 | 97 | 382 |
| 40–49 years | 335 | 114 | 449 |
| 50–59 years | 473 | 125 | 598 |
| 60–69 years | 485 | 270 | 755 |
| 70–79 years | 426 | 139 | 565 |
| 80+ years | 215 | 44 | 259 |
| Unknown | 371 | 664 | 1,035 |
| Total | 3,186 | 2,329 | 5,515 |
Notes:
- Non-vaccine includes medicines, vitamins, dietary supplements and any other substance that is not a vaccine.
- The vaccine reports include COVID-19 vaccines.
Figure 1 shows the proportion of reports by report type and age band for 2023. 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 1: Proportion of reports by report type and age band (years), 2023
Reports by substance
Tables 5 to 7 show the most frequently reported substances for 2023. The Comirnaty COVID-19 vaccine was the most frequently reported vaccine (945 reports) and clozapine the most frequently reported non-vaccine substance (294 reports).
Table 5: Top 10 most frequently reported suspect substances, all reports (non-vaccines + vaccines), 2023
| Substance | Type | No. reports |
|---|---|---|
| Comirnaty vaccine | Vaccine | 945 |
| Meningococcal B vaccine | Vaccine | 386 |
| Clozapine | Non-vaccine | 294 |
| Iohexol | Non-vaccine | 287 |
| Influenza vaccine polyvalent | Vaccine | 262 |
| Diphtheria + Tetanus + Pertussis + Polio vaccine | Vaccine | 219 |
| Shingles (varicella zoster) vaccine | Vaccine | 182 |
| Diphtheria + Tetanus + Pertussis vaccine | Vaccine | 112 |
| Pneumococcal conjugate vaccin | Vaccine | 105 |
| Measles + Mumps + Rubella vaccine | Vaccine | 104 |
Notes:
- Comirnaty vaccine includes the monovalent (tozinameran) and bivalent (tozinameran + famtozinameran) COVID-19 vaccines.
- Pneumococcal conjugate vaccine includes PCV13 (Prevenar 13) and PCV10 (Synflorix) vaccines.
Table 6: Top 10 most frequently reported suspect non-vaccine substances, 2023
| Non-vaccine substance | No. |
|---|---|
| Clozapine | 294 |
| Iohexol | 287 |
| Empagliflozin | 84 |
| Adalimumab | 77 |
| Ferric carboxymaltose | 74 |
| Nirmatrelvir + Ritonavir | 64 |
| Infliximab | 63 |
| Lenalidomide | 61 |
| Zoledronic acid | 55 |
| Sulfamethoxazole + Trimethoprim | 48 |
Table 7: Top 10 most frequently reported vaccines, 2023
| Vaccine | No. |
|---|---|
| Comirnaty vaccine | 947 |
| Meningococcal B vaccine | 386 |
| Influenza vaccine polyvalent | 262 |
| Diphtheria + Tetanus + Pertussis + Polio vaccine | 217 |
| Shingles (varicella zoster) vaccine | 182 |
| Diphtheria + Tetanus + Pertussis vaccine | 110 |
| Pneumococcal conjugate vaccine | 105 |
| Measles + Mumps + Rubella vaccine | 104 |
| Diphtheria + Tetanus+ Pertussis + Poliomyelitis + Hepatitis B + Haemophilus influenzae type b vaccine | 68 |
| Haemophilus influenzae type b vaccine | 53 |
Notes:
- Comirnaty vaccine includes the monovalent (tozinameran) and bivalent (tozinameran + famtozinameran) COVID-19 vaccines.
- 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, headache was the most frequently reported reaction (332 reports), followed by nausea (323 reports). For non-vaccines, urticaria (247) and rash (200) were most frequently reported. For vaccines, injection site inflammation (283) and pyrexia (269) were the most frequently reported reactions.
Table 8: Top 10 most frequently reported adverse reactions, all reports (non-vaccines + vaccines), 2023
| Reaction | No. |
|---|---|
| Headache | 332 |
| Nausea | 323 |
| Pyrexia (fever) | 320 |
| Urticaria (raised, itchy rash) | 319 |
| Rash | 305 |
| Fatigue | 290 |
| Injection site pain | 286 |
| Injection site inflammation | 285 |
| Dizziness | 258 |
| Vomiting | 258 |
Notes:
- Non-vaccine includes medicines, vitamins, dietary supplements and any other substance that is not a vaccine.
- The vaccine data includes reports for COVID-19 vaccines.
Table 9: Top 10 most frequently reported adverse reactions for non-vaccine substances, 2023
| Reaction | No. |
|---|---|
| Urticaria (raised, itchy rash) | 247 |
| Rash | 200 |
| Pruritus (itching) | 197 |
| Nausea | 164 |
| Anaphylactic reaction | 129 |
| Vomiting | 128 |
| Headache | 111 |
| Dizziness | 102 |
| Diarrhoea | 97 |
| Dyspnoea (shortness of breath) | 92 |
| Neutropenia (low levels of neutrophils – a type of white blood cell) | 92 |
Notes:
- Non-vaccine includes medicines, vitamins, dietary supplements and any other substance that is not a vaccine.
- 11 different reactions are shown because Dyspnoea and Neutropenia had the same number of reports.
Table 10: Top 10 most frequently reported adverse reactions for vaccines, 2023
| Reaction | No. |
|---|---|
| Injection site inflammation | 283 |
| Pyrexia (fever) | 269 |
| Injection site pain | 259 |
| Headache | 222 |
| Fatigue | 220 |
| Injection site erythema (redness) | 214 |
| Pain in extremity (arm or leg pain) | 195 |
| Nausea | 160 |
| Dizziness | 157 |
| Injection site swelling | 149 |
Notes:
- The vaccine data includes reports for COVID-19 vaccines.
Who is reporting?
Anyone can submit a report. Table 11 shows the number of reports by reporter type received in 2023. Members of the public submitted the most reports (2,220), followed by Other healthcare professionals (1,043) and Hospital doctors (882).
Table 11: Number of reports received by reporter type, 2023
| Reporter | No. |
|---|---|
| Public | 2,220 |
| Other healthcare professional | 1,043 |
| Hospital doctor | 882 |
| Nurse | 613 |
| Pharmacist | 506 |
| General practitioner | 251 |
| Total | 5,515 |
Notes:
- Public includes consumers and non-healthcare professionals.
- Pharmaceutical companies receive reports from a variety of reporters (eg, nurses, public, GPs) and then submit the reports to the New Zealand Pharmacovigilance Database. These reports are coded as per the original reporter, not the pharmaceutical company.
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
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:
