133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
25 October 2023
W www.medsafe.govt.nz
Catherine Jamieson
By email: [FYI request #23989 email]
Ref:
H2023032268
Tēnā koe Catherine
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) to Manatū Hauora
(the Ministry of Health) on 9 October 2023 for information regarding Medsafe’s safety reports and
suspected medicine adverse reaction search (SMARS) online database system. You requested:
“OIA response H2023021744 identifies a significant difference between the serious adverse
event reports received and those publicly reported through Medsafe Safety Reports and
SMARS. Please supply any reports, emails or other correspondence pertaining to the
difference between reports of adverse events following immunisation with Covid vaccines
received and those reported in Medsafe Safety Report #46.
How many adverse event reports following immunisation have been received to date for
Covid vaccines, both total reports and those that fall under the Medsafe definition of
serious?”
As you were advised in your previous response (H2023031262 refers), the difference in data was
due to the COVID-19 vaccine reports not being fully integrated into the normal the Centre for
Adverse Reactions Monitoring (CARM) database. Since the databases have not yet been joined
a line listing for COVID19 vaccine reports was publishe
d www.medsafe.govt.nz/safety/reports-
and-promotion/ADRreporting-statistics.asp.
Data reported to the Centre for Adverse Reactions Monitoring is published here:
www.medsafe.govt.nz/safety/reports-and-promotion/ADRStatistics/Comirnaty2023.asp.
Medsafe stands by its original decision and has nothing further to add.
Under section 28(3) of the Act, you have the right to ask the Ombudsman to review any decisions
made under this request. The Ombudsman may be contacted by email at:
[email address] or by calling 0800 802 602.
Please note that this response, with your personal details removed, may be published on the
Manatū Hauora website at:
www.health.govt.nz/about-ministry/information-releases/responses-
official-information-act-requests.
Nāku noa, nā
Chris James
Group Manager
Medsafe
