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2 Processes for safe immunisation

2.5 AEFI reporting process – notifying CARM

When obtaining consent for immunisation, vaccinators should also seek consent to report any adverse events that may occur, because AEFI reporting is considered part of immunisation programme quality control monitoring and public safety.

Health professionals are professionally and ethically responsible for reporting serious or unexpected adverse events that occur after the administration of all medicines, including vaccines. Serious events are defined as those that significantly affect an individual’s health, including reactions suspected of causing:

Some providers are able to report events through their practice management system. Reports can also be completed online (https://nzphvc.otago.ac.nz/reporting), or the form can be downloaded and printed using the above link, completed and mailed to:

Freepost 112002
The Medical Assessor
Centre for Adverse Reactions Monitoring (CARM)
University of Otago Medical School
PO Box 913
Dunedin, 9710

or faxed to:

(03) 479 7150.

The information required in the reporting form covers:

2.5.1 What should be reported?

Health professionals/vaccinators should report any serious or unexpected AEFI (regardless of whether or not they consider the event to have been caused by the vaccination), such as those described in Table 2.9 below.

Individuals or parents/guardians should be encouraged to notify vaccinators of any AEFI which they consider may have been caused by the vaccination. Alternatively, individuals or parents/guardians may wish to notify CARM themselves, or they can contact their general practice or IMAC (0800 IMMUNE / 0800 466 863) to notify on their behalf.

CARM prefers reports from health professionals – doctors, other prescribers, pharmacists and nurses. When consumers report to CARM, the individual’s health practitioner should be involved, where possible.

Table 2.9: AEFIs to be reported

Timeframe Event
Within 24 hours of vaccination Anaphylactic reaction (acute hypersensitivity reaction)

Anaphylaxis

Persistent inconsolable screaming (more than three hours)

Hypotonic-hyporesponsive episode (HHE)

Fever >40oC
Within 5 days of vaccination Severe local reaction

Sepsis

Injection site abscess
Within 12 days of vaccination Seizures, including febrile seizures

Encephalopathy
Within 3 months of vaccination Acute flaccid paralysis* (AFP), including Guillain-Barré syndrome

Brachial neuritis (usually occurs 2–28 days after tetanus-containing vaccine)

Thrombocytopenia (usually occurs 15–35 days after MMR)
Between 1 and 12 months after BCG vaccination Lymphadenitis

Disseminated BCG infection

​Osteitis/osteomyelitis
No time limit Intussusception after rotavirus vaccine

Any death, hospitalisation, or other severe or unusual events of clinical concern that are thought by health professionals or the public to possibly be related to vaccination

* AFP in children is also monitored by the New Zealand Paediatric Surveillance Unit (NZPSU) as part of polio eradication surveillance (see chapter 16).

2.5.2 CARM assessment of causalityTop

Each report received by CARM is evaluated by a medical assessor to determine the likelihood of an association between the adverse event and the medicine.

The person reporting the event will receive a letter of response from CARM commenting on the adverse effect, the causal relationship, the number of other similar events, and advice about future use of the vaccine in the individual. Also, where applicable, CARM will provide a validated AEFI code to the NIR.

The information provided by CARM: