133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
28 April 2026
A Goodwin
By email: [FYI request #34390 email]
Ref:
H2026081053
Tēnā koe
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 6 April 2026. Please find a response to each part of
your request below.
1) At paragraph 310 of the Covid Inquiry Phase 2 report, it is noted that Medsafe
recommended a plan to strengthen existing arrangements to monitor COVID-19 vaccine
safety. Please provide details of this plan including the document mentioned at footnote
289 – “A COVID-19 Vaccine Safety Surveillance Strategy for New Zealand: Framework
Proposal for Discussion, New Zealand Pharmacovigilance Centre – University of Otago
(28 September 2020)”
The document you have requested is attached to this letter as Appendix 1. This is released to
you with some information withheld under section 9(2)(g)(ii) of the Act, to protect Ministers,
members of organisations, officers, and employees from improper pressure or harassment.
Where information is withheld under section 9 of the Act, I have considered the public interest in
the release of this information and do not deem it to outweigh the need to withhold it in this case.
2) In reference to paragraph 304 of the Covid Inquiry Phase 2 report, please provide the
list of ‘critical terms’ compiled by CARM/Medsafe assessors that they considered should
trigger an adverse event report to be reviewed.
Please refer to Appendix 2 below. Note that this list was not static – items were added and
removed over time and therefore, the list may not necessarily be complete or represent the
whole monitoring period.
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 calling 0800 802 602.Please note that this response, with
your personal details removed, may be published on the Ministry website at:
www.health.govt.nz/about-ministry/information-releases/responses-official-information-act-
requests. Nāku noa, nā
Chris James
Group Manager
Medsafe
Page 2 of 5
Appendix 2: List of ‘critical terms’
• Abortion spontaneous
• Subarachnoid haemorrhage
• Kawasaki’s disease
• Thromboembolic stroke
• Acute kidney injury
• Pulmonary embolism
• Encephalopathy
• Cerebral thrombosis
• Tachyarrhythmia
• Capillary leak syndrome
• Immune thrombocytopenia
• Intracranial pressure increased
• Haematuria
• Uveitis
• Hemorrhagic stroke
• Status epilepticus
• Henoch–Schönlein purpura
• Myeloid leukaemia
• Arterial thrombosis
• Dermatitis exfoliative
• Leukocytosis
• Neonatal death
• Thrombosis
• Face oedema
• Guillain–Barré syndrome
• Vaginal bleeding
• Thrombotic thrombocytopenic
• Sjögren’s syndrome
purpura
• Grand mal convulsions
• Myoclonic seizure
• Gastrointestinal necrosis
• Encephalitis
• Tetanus
• Multiple sclerosis
• Bell’s palsy
• Squamous cell carcinoma
• Loss of consciousness
• Meningioma
• Sudden death
• Foetal disorder
• Seizure
• Meningitis bacterial
• Leukocytoclastic vasculitis
• Aortic stenosis
• Dystonia
• Multisystem inflammatory syndrome
• Meningitis
• Cyanosis
• Bronchospasm aggravated
• Intestinal necrosis
• Absence seizure
• Venous thrombosis
• Haemorrhagic stroke
• Purpura thrombocytopenic
• Circulatory shock
• Bronchospasm
• Leukaemia
• Blindness
• Lymphatic leukaemia
• Acute disseminated
• Encephalomyelitis
encephalomyelitis
• Amaurosis fugax
• Transient ischemic attack
• Venous thromboembolism
• Haemophilia
• Haemorrhage
• Sudden death
• Arterial thromboembolism
• Anaphylactoid reaction
• Embolism
• Respiratory failure
• Thrombophlebitis
• Serum sickness
• Myeloid leukaemia
• Meningitis viral
• Tonic-clonic seizure
• Thromboembolism
• Unconsciousness
Page 3 of 5
• Transverse myelitis
• Ankylosing spondylitis
• Myocarditis
• Electrocardiogram QT prolonged
• Facial palsy
• Foetal death
• Myocardial infarction
• Convulsions
• Vasculitis
• Malignant neoplasm
• Respiratory arrest
• Oral mucosa blistering
• Asphyxia
• Liver injury
• Shock
• Thrombotic stroke
• Face oedema
• Erythema multiforme
• Foetal distress syndrome
• Retinopathy
• Sarcoma
• Systemic lupus erythematosus
• Cerebral venous sinus thrombosis
• Cardiomyopathy
• Ischaemic stroke
• Pericardial effusion
• Anaphylactic shock
• Myelodysplastic syndrome
• Meningism
• Postherpetic neuralgia
• Intussusception
• Conversion disorder
• Death
• Autoimmune haemolytic anaemia
• Stroke
• Suppressed lactation
• Thrombocytopenia
• Bronchiectasis
• Peripheral cyanosis
• Cardiomegaly
• Pancreatitis
• Weight increased
• Aseptic meningitis
• Parkinson’s disease
• Brain oedema
• Bundle branch block
• Chilblains
• Tubulointerstitial nephritis
• Pulmonary thromboembolism
• Exercise tolerance decreased
• Pericarditis
• Atrioventricular block
• Facial paralysis
• Thyroiditis
• Foetal hypokinesia
• Bacterial endocarditis
• Sepsis
• Intestinal ischaemia
• Deep vein thrombosis (DVT)
• Restless legs syndrome
• Stevens–Johnson syndrome
• Trigeminal neuralgia
• Polymyalgia rheumatica
• Hypoalbuminaemia
• Type 2 diabetes mellitus
• Menopausal symptoms
• Myasthenia gravis-like syndrome
• Vitreous detachment
• Myelitis
• Hypokalaemia
• Hypersensitivity vasculitis
• Akathisia
• Type 1 diabetes mellitus
• Cardiac sarcoidosis
• Skin necrosis
• Vitiligo
• Anaphylaxis
• Aortic dissection
• Coma
• Postmenopausal haemorrhage
• Thrombocytopenic purpura
• Sarcoidosis
• Foetal growth restriction
• Coronary artery disease
Page 4 of 5
• Anhidrosis
• Ejaculation disorder
• Condition aggravated
• Hypophosphataemia
• Congestive cardiomyopathy
• Ruptured aneurysm
• Diverticulitis
• Ectopic pregnancy
• Fasciitis
• Nerve injury
Page 5 of 5
