133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
2 July 2024
Catherine Jamieson
By email: [FYI request #27095 email]
Ref:
H2024043265
Tēnā koe Catherine
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) to the Ministry of
Health – Manatū Hauora (the Ministry) on 31 May 2024 for:
“As provided in H2023033887 for batches FK0892, FK9797, FF2387, FE8163, FK0115,
FH4752 and FK9414 please provide the number of adverse events reported to CARM
following Covid injection by Pfizer batch for the batches not included in the list above.”
Medsafe does not hold information on any batches outside of those listed. Your request is
therefore refused under section 18(e) of the Act, as the document alleged to contain the
information requested does not exist.
If it is of use, Medsafe can provide a more detailed spreadsheet of the listed batches and number
of adverse events following immunisation (AEFI) reported for each batch. A copy of this is
attached. In receiving this spreadsheet, please consider the following caveats:
• Reporting suspicions of an adverse event to a vaccine is voluntary. Therefore, the AEFI
reports provided to the Centre for Adverse Reactions Monitoring (CARM) represent a
fraction of the total number of AEFI’s.
• In order to report an AEFI, a link must be made between an event and the vaccine by the
person who experienced the AEFI or the healthcare professional they consulted about the
event.
• In order to report an AEFI, the person and/or their healthcare professional must know how
to report an AEFI and have the time to report an AEFI.
• Reporting may be influenced by many factors such as media publicity. Therefore, the
proportion of events reported is likely to change over time.
• There may be a difference in reporting in different age groups, genders, vaccination sites
and ethnicity.
• Reporters may choose to report a diagnosis which would be counted as one event or the
symptoms of the condition/diagnosis, which wil be many events. The Ministry considers
that the two reports would essentially be the same, but for the purposes of this request
would have a significant effect on the numbers requested.
• The batch number is as reported, and the Ministry does not know how accurate the
recording of batches was.
• The Ministry does not know the size of the batches (and each batch may have been
distributed across several countries).
• The Ministry does not know how many doses were obtained from each of the multidose
vials.
• The Ministry does not know how much wastage there was from each batch.
• The Ministry does not know if batches were distributed evenly throughout the country, or if
there was regional variation which may have coincided with a regional variation in
reporting.
I trust this information fulfils your request. If you wish to discuss any aspect of your request with
us, including this decision, please feel free to contact the OIA Services Team
on:
[email address].
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 cal ing 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
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