INOPP Forum
How does MedSafe monitor vaccine safety?
Quote from VigiServe Admin on January 26, 2021, 2:27 PMAll vaccines have the potential to cause adverse reactions in some people. Most adverse reactions following vaccination are mild and short-lived. However, some vaccines may rarely cause more serious reactions.
Medsafe continually reviews all vaccines approved for use in New Zealand and takes appropriate action if any risks are identified.
Medsafe routinely uses information from many different sources to monitor vaccine safety including:
- clinical and epidemiological studies
- case reports
- published literature
- pharmaceutical companies
- other regulatory authorities.
In addition, vaccines adverse events are reported to the Centre for Adverse Reactions Monitoring (CARM). CARM inform Medsafe and the Medicines Adverse Reactions Committee if they detect a possible safety problem with any vaccine. These reports are often referred to as adverse events following immunisation (AEFI) rather than suspected adverse reactions.
Healthcare professionals and consumers are encouraged to report any suspicions that an event may have been caused by vaccination. Reports sent to CARM may describe:
- real adverse reactions to the vaccine
- anxiety events or nervousness about needles or the process of vaccination
- coincidental events that would have occurred anyway.
What events are expected to be reported after immunisation?
With any vaccine, the following types of suspected adverse reactions are expected to be reported.
- Injection site reactions (eg, pain, swelling).
- 'Well-recognised' events such as headaches, dizziness, muscle aches, mild fever and tiredness.
- Mild allergic reactions such as mild rashes and itching.
- A few serious allergic reactions (healthcare professionals giving vaccines are trained to spot the symptoms of serious allergic reactions and treat them).
- Events due to fear or anticipation of the needle injection, such as fainting.
- Coincidental medical conditions (eg, neurological disorders).
- New adverse reactions (ie, those not already listed in the datasheet).
In New Zealand, it is unlikely that rare side effects to vaccines will be detected as the population immunised is usually too small. Therefore, Medsafe uses international data to help determine if these rare events may be due to immunisation.
All vaccines have the potential to cause adverse reactions in some people. Most adverse reactions following vaccination are mild and short-lived. However, some vaccines may rarely cause more serious reactions.
Medsafe continually reviews all vaccines approved for use in New Zealand and takes appropriate action if any risks are identified.
Medsafe routinely uses information from many different sources to monitor vaccine safety including:
- clinical and epidemiological studies
- case reports
- published literature
- pharmaceutical companies
- other regulatory authorities.
In addition, vaccines adverse events are reported to the Centre for Adverse Reactions Monitoring (CARM). CARM inform Medsafe and the Medicines Adverse Reactions Committee if they detect a possible safety problem with any vaccine. These reports are often referred to as adverse events following immunisation (AEFI) rather than suspected adverse reactions.
Healthcare professionals and consumers are encouraged to report any suspicions that an event may have been caused by vaccination. Reports sent to CARM may describe:
- real adverse reactions to the vaccine
- anxiety events or nervousness about needles or the process of vaccination
- coincidental events that would have occurred anyway.
What events are expected to be reported after immunisation?
With any vaccine, the following types of suspected adverse reactions are expected to be reported.
- Injection site reactions (eg, pain, swelling).
- 'Well-recognised' events such as headaches, dizziness, muscle aches, mild fever and tiredness.
- Mild allergic reactions such as mild rashes and itching.
- A few serious allergic reactions (healthcare professionals giving vaccines are trained to spot the symptoms of serious allergic reactions and treat them).
- Events due to fear or anticipation of the needle injection, such as fainting.
- Coincidental medical conditions (eg, neurological disorders).
- New adverse reactions (ie, those not already listed in the datasheet).
In New Zealand, it is unlikely that rare side effects to vaccines will be detected as the population immunised is usually too small. Therefore, Medsafe uses international data to help determine if these rare events may be due to immunisation.
Quote from VigiServe Admin on January 26, 2021, 2:28 PMReport an adverse event to vaccines
The collection of adverse events to medicines (including vaccines) is contracted to the Centre for Adverse Reactions Monitoring (CARM) at the University of Otago.
Online Submit a consumers online report
Submit a healthcare professionals online report
Prescribers can also submit a report using the online reporting tool available in patient management software.Paper Download a consumer reporting form (Word Document, 61KB, 1 page) and submit completed forms to CARM via email, fax or mail (NZPhvC, University of Otago Medical School, PO Box 913, Dunedin 9054)
Download a healthcare professional reporting form and submit to CARM via email, fax or mail (NZPhvC, University of Otago Medical School, PO Box 913, Dunedin 9054).carmnz@otago.ac.nz Phone 03 479 7247 to speak to a Medical Advisor at CARM.
Use the iPhone reporting applicationFax 03 479 7150
Report an adverse event to vaccines
The collection of adverse events to medicines (including vaccines) is contracted to the Centre for Adverse Reactions Monitoring (CARM) at the University of Otago.
| Online | Submit a consumers online report Submit a healthcare professionals online report Prescribers can also submit a report using the online reporting tool available in patient management software. |
| Paper | Download a consumer reporting form (Word Document, 61KB, 1 page) and submit completed forms to CARM via email, fax or mail (NZPhvC, University of Otago Medical School, PO Box 913, Dunedin 9054) Download a healthcare professional reporting form and submit to CARM via email, fax or mail (NZPhvC, University of Otago Medical School, PO Box 913, Dunedin 9054). |
| carmnz@otago.ac.nz | |
| Phone | 03 479 7247 to speak to a Medical Advisor at CARM. Use the iPhone reporting application |
| Fax | 03 479 7150 |