12 December 2023

Safety Information

How to Search SMARS

Medsafe advises patients NOT to make any changes to their medicine treatment based on information contained in SMARS. Changes to treatment should only be made following consultation with a healthcare professional.

You can search for a vaccine or a medicine in SMARS. You can also choose the report date period and the type of search (detail or summary).

Vaccine search

Select 'Vaccine' in the 'Type' box.

You can either:

  • type first few letters of the vaccine name into the 'Select Ingredient' box, or
  • click on the dropdown box to view the full list.

The dropdown ingredient list includes a list of synonyms (alternative names). If one of these is selected, the name in the ingredients field in the search results will change to the Medsafe preferred name.

If you are unsure of the vaccine's ingredients, try using the Product search link (next to the Search Ingredient box). This link takes you to the Medsafe Product/Application Search where you can find the ingredients of a vaccine. Note that many vaccines have more than one ingredient. You only need to search on one of these.

Then enter the report date period.

COVID-19 vaccines

The active ingredients in the COVID-19 vaccines have various names. Table 1 below lists the dropdown box options and what the search results will show for each option.

Table 1: COVID-19 vaccine search options and results

Ingredient in dropdown box Will return search results for:*
AZD-1222 Vaxzevria
BNT162b2 [mRNA]
  • Comirnaty Original/Omicron
  • Comirnaty (Pfizer-BioNTech)
ChAdOx nCov-19 Vaxzevria
ChAdOx1-S Vaxzevria
Comirnaty omicron BA. 4-5 Comirnaty Original/Omicron
Comirnaty original
  • Comirnaty Original/Omicron
  • Comirnaty (Pfizer-BioNTech)
Elasomeran Moderna COVID-19 vaccine
Famtozinameran Comirnaty Original/Omicron
Moderna COVID-19 vaccine Moderna COVID-19 vaccine
mRNA-1273 Moderna COVID-19 vaccine
Nuvaxovid COVID-19 vaccine Nuvaxovid with Matrix-M Adjuvant (Novavax)
NVX-CoV2373 Nuvaxovid with Matrix-M Adjuvant (Novavax)
Raxtozinameran Comirnaty Omicron XBB.1.5
SARS-CoV-2 rs Nuvaxovid with Matrix-M Adjuvant (Novavax)
TAK-919 Nuvaxovid with Matrix-M Adjuvant (Novavax)
Tozinameran
  • Comirnaty Original/Omicron
  • Comirnaty (Pfizer-BioNTech)
Vaxzevria (COVID-19 Vaccine AstraZeneca) Vaxzevria

* To search only for the Comirnaty Original/Omicron vaccine (ie, the bivalent vaccine), select 'Comirnaty omicron BA. 4-5' or 'Famtozinameran' from the dropdown box.

Medicine search

Select 'Medicine' in the 'Type' box.

You can either:

  • type first few letters of the medicine name into the 'Select Ingredient' box, or
  • click on the dropdown box to view the full list.

The ingredient list includes a list of synonyms (alternative names), if one of these is selected the name in the ingredient field will change to the Medsafe preferred name.

If you are can't find the name of the medicine you are interested in, try using the Product search link (next to the Search Ingredient box). This link takes you to the Medsafe Product/Application Search where you can find the ingredients of medicines.

If a suspected adverse reaction has been reported for the product you are interested in and this product name has been recorded, it will be displayed in the 'Detail' search after you have searched using its ingredient.

Enter the report date period

You can refine your search to a date range. If no dates are added the search will automatically include all reports in the database. Add the date as DD MMM YYYY (eg, 31 Aug 2023).

Note that even though the database is updated each month, the search results will always be two months in arrears, as we do not include reports from the last two months.

Select the search type

There are two search types, 'Detail' and 'Summary'.

Detail report

If a suspected adverse reaction has been reported for the product you are interested in and this product name has been recorded, it will be displayed in the 'Detail' search after you have searched using its ingredient.

The total number of reports and reactions are displayed at the top of the table.

The number of reports where death was reported indicates that the reporter stated that the patient had died. The death may have been due to the patient's underlying condition, coincidental event or due to an adverse reaction.

The number of reactions will be greater than the number of reports as some patients experience more than one suspected adverse reaction.

Report: This is the reference number for the case.
Date: This is the date of the report, not the date of the suspected reaction. Note that not all reports are submitted at the time of the suspected reaction(s).
Gender: If reported. If the gender was not reported or not known, 'Unknown' will be displayed in the results table.
Age: This is the age of the patient, in years, at the time of the reaction. For children under 1 year, the age in months is displayed. If the age was not reported or not known, this field will be blank in the results table.
Medicines: This is a list of the medicines or vaccines reported for that case. The brand name will be displayed if it has been recorded in the database. The suspected medicines or vaccines in the case are qualified with '(Suspect)', interacting medicines or vaccines with '(Interacting)' and other medicines or vaccines with '(Concomitant)'. In some cases the exact medicine or vaccine is not known but the type is. In these cases the type of medicine or vaccine is displayed followed by 'unclassified' or 'NOS' (Not Otherwise Specified).
Reactions: The suspected reactions are displayed using the preferred terms contained in the MedDRA dictionary. There may be more than one suspected reaction per case.

Summary report

The total number of reports and reactions are displayed at the top of the table.

The number of reports where death was reported indicates that the reporter stated that the patient had died. The death may have been due to the patient's underlying condition, coincidental event or due to an adverse reaction.

The number of reactions will be greater than the number of reports as some patients experience more than one suspected adverse reaction.

Systerm Organ Class: These suspected reactions are grouped according to different body systems or organs, eg, 'Cardiac disorders' shows cardiac (heart) related reactions.
MedDRA Reaction Term The suspected reactions are displayed using the preferred terms contained in the MedDRA dictionary.
Number of Reports The number of suspected adverse reactions reported.
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