Annotation: Transparency in COVID-19 Vaccine Warnings and Adverse Event Reporting – Insights from OIA Request #32014

For New Zealanders Following Vaccine Safety Discussions

This annotation provides a neutral, fact-based overview of Official Information Act (OIA) request #32014 on fyi.org.nz, submitted by Chris McCashin to Health New Zealand (Te Whatu Ora) on August 18, 2025. The request sought copies of all pre-vaccination warnings (e.g., pamphlets, consent forms) about COVID-19 vaccine risks and a comprehensive list of adverse events reported to the Centre for Adverse Reactions Monitoring (CARM), including descriptions, report numbers, and time periods—specifically on Health NZ letterhead. As of September 16, 2025, the request remains unresolved, highlighting ongoing challenges in accessing detailed, centralized vaccine safety data in Aotearoa. This note draws from the FYI page, Medsafe resources, and related public NZ sources to flag potential gaps in transparency, such as omissions in disclosed risks, misdirection via public tools, and procedural delays/transfers.

Summary of the OIA Process and Responses

• Initial Response (September 8, 2025): Health NZ partially addressed the warnings request by providing a 52-page Appendix One (HNZ00096052 Appendix One.pdf), containing various leaflets and consent forms produced since 2021 by the Immunisation Advisory Centre (IMAC) and Medsafe. These materials (e.g., “Your COVID-19 Vaccination: Everything You Need to Know” for ages 12+ and 16+) emphasize:
◦ How the vaccine works (teaching the body to fight the virus without causing illness).
◦ Safety assurances (assessed by Medsafe experts, no shortcuts, monitored globally).
◦ What to share pre-vaccination (e.g., allergies, bleeding disorders).
◦ Mild side effects (e.g., muscle aches, headache, fever, injection site pain—common after second dose, resolve quickly).
◦ Rare serious effects (anaphylaxis: seek immediate help for rash/swelling; myocarditis/pericarditis: chest pain/breathing issues).
◦ Post-vaccination advice (wait 15-20 minutes, report via Healthline, continue protections like masking/tracing).
• The response notes these were updated over time and directs to online sources (e.g., health.govt.nz, medsafe.govt.nz) for further info, but does not provide every historical version. For CARM data, it declines to compile a list, instead pointing to Medsafe’s public Suspected Medicine Adverse Reaction Search (SMARS) tool at medsafe.govt.nz/SMARS, claiming the requested details are “publicly available” there.
• Follow-Up (September 11, 2025): McCashin reiterated the need for the CARM list on letterhead, referencing Pfizer’s post-marketing report (allegedly listing extensive serious effects) and questioning NZ’s ongoing vaccine use despite reported issues.
• Transfer to Medsafe (September 2025): Health NZ transferred the full request to the Ministry of Health (Medsafe) under OIA section 14(b)(ii), stating adverse reactions fall under their remit. No new data was provided; users are again directed to Medsafe’s adverse reactions page. As of September 16, 2025, no further updates on fyi.org.nz—no Medsafe response, no new attachments, and status listed as “unknown.” 21 McCashin has submitted 154 similar OIAs on health topics, including vaccine compensation and reporting, but none show resolutions for 2025 CARM specifics yet.

Analysis: Potential Omissions, Misdirection, Delays, and Obfuscation

While the OIA process operated within legal timelines (initial response within 20 working days), the handling raises questions about accessibility and completeness for public scrutiny—especially amid calls for “Safe & Effective” transparency.

Here’s a breakdown based on NZ resources:
• Omissions in Warnings Materials:
◦ The provided leaflets (Documents 1 and 2 in Appendix One) focus on mild, temporary effects and only two rare serious ones (anaphylaxis, myocarditis). They omit broader reported events like blood clots (e.g., thrombosis with thrombocytopenia syndrome, TTS), neurological issues (e.g., Guillain-Barré syndrome, Bell’s palsy), or menstrual changes—despite international and NZ monitoring of these as Adverse Events of Special Interest (AESIs). 13 Consent forms require acknowledging “risks and side effects” but don’t list them exhaustively,

potentially understating the full spectrum.
◦ No mention of long-term monitoring data or deaths (e.g., 184 reported to CARM by late 2022, with only 4 potentially linked). 12 Post-2022 updates are absent; Medsafe’s last public AEFI summary (#46, December 2022) covered ~11.9 million doses with 64,829 reports (5.45 per 1,000), but 2023-2025 data relies on individual SMARS searches, not summaries. 14 A September 3, 2025, Health NZ page on side effects similarly limits to basics and directs reporting to CARM, without aggregated stats. 11
• Misdirection and Obfuscation via Public Tools:
◦ Directing to SMARS (a search database) fulfills a technical public availability claim but misdirects from the request’s core ask: a compiled, letterhead list with counts and periods. SMARS requires manual queries (e.g., by vaccine/reaction term), yielding anonymized, non-causal data without easy exports—making comprehensive review cumbersome for non-experts. For instance, searching “Comirnaty myocarditis” shows 974 reports (up to 2022), but full AESI lists (e.g., 35 Guillain-Barré, 130 deep vein thrombosis) aren’t pre-summarized post-2022. 12
◦ Medsafe’s COVID-19 vaccines page (last updated August 2024) lists 46 AEFI reports to 2022 but notes ongoing CARM monitoring without 2025 specifics or OIA mentions. 12 A 2023 database upgrade shifted processing to Medsafe, potentially streamlining but not yet yielding public COVID summaries. 16 This could obscure trends, as reports include non-causal events, and causality assessments (e.g., via Brighton Collaboration) aren’t highlighted.
• Delays and Transfers:
◦ No explicit delays, but the transfer (post-September 11 follow-up) extends timelines—Medsafe has up to 20 working days from receipt (potentially early October 2025). Similar OIAs (e.g., on CARM/MoH reporting) show patterns of transfers between agencies, prolonging access. 18 Older OIA responses (e.g., 2021-2023) reveal similar deferrals on vaccine harms, with limited details on diagnostics or treatments for reactions. 8 9 No 2025 Medsafe response to this specific OIA is public yet.
These patterns align with broader critiques in NZ media and OIAs: While benefits outweigh risks per Medsafe (no new concerns post-2022), the lack of updated, user-friendly aggregates may hinder informed consent and public trust.

What Public Data Is Available?

• SMARS Tool: Free at medsafe.govt.nz/SMARS—search by vaccine (e.g., Comirnaty/Pfizer) for reaction counts. Covers all reports, but filter for time periods.
• Historical Reports: Medsafe’s 46 AEFI summaries (up to November 2022) detail top events (e.g., headache: 19,679 reports) and AESIs. 2023 ADR stats (released January 2025) include all medicines but not COVID-specific breakdowns. 14
• Safety Alerts: Medsafe’s page lists dated alerts (e.g., myocarditis in youth, July 2021; TTS rare post-AstraZeneca, now phased out). No new 2023-2025 alerts signal emerging issues.
• Reporting: Anyone can submit via CARM form at pophealth.my.site.com/carmreportnz/s/. 15 Health NZ encourages this for ongoing monitoring.
Vaccines remain available; consult your doctor for personalized advice.

Recommendations for Followers

• Monitor fyi.org.nz/request/32014 for Medsafe’s response.
• If concerned, file your own OIA to Medsafe for 2025 CARM data or complain to the Ombudsman (ombudsman.parliament.nz, 0800 802 602) if timelines slip.
• Cross-reference with independent sources like the COVID-19 Vaccine Study Group or international data (e.g., WHO VigiBase), but prioritize NZ experts.
• For community discussion, check NZ-focused forums or news (e.g., NZ Doctor on AEFI #33).

This annotation aims to empower informed engagement—transparency strengthens our health system. Last updated based on data as of September 16, 2025.