The Health and Disability Commissioner has criticised a pharmacist for not providing enough information to Rory Nairn before he received the Pfizer Covid-19 vaccine.
The 26-year-old Dunedin plumber died on 17 November 2021, 12 days after he was vaccinated against the virus.
A coronial inquest into the death in 2022 found his death
was caused by myocarditis defined as inflammation of the heart muscle.
"I find that Rory James Nairn, aged 26, died on 17 November 2021 at ... Dunedin. The cause of his death was myocarditis, due to vaccination with the Comirnaty TM Pfizer/BioN Tech Covid-19 vaccine," coroner Sue Johnson said.
"My inquiry into Rory's death is not yet concluded. I have yet to establish the circumstances of his death."
But in further findings released on Monday, Johnson said the pharmacist who administered the jab did not inform Nairn of myocarditis because it was deemed "a very rare side-effect of the vaccine".
In the following days following the vaccination, Nairn complained several times about his chest feeling "weird".
On 17 November, he told his fiancée of the same feeling in the chest.
They discussed going to the hospital, but he said he would go to his own doctor later that morning.
He later collapsed and died in the couple's bathroom.
The pharmacist had previously told the inquest she was not made aware of an expectation to inform patients of rare side-effects.
"This was because there had been material received through a number of sources detailing that risk.
"But she also said that she was not aware of any requirement to specifically discuss that with a customer on or before 5 November 2021.
"And that on the instructions of [her operating manager], she did not advise customers for vaccination about rare side-effects of the vaccine, such as myocarditis."
The pharmacy manager also gave similar evidence, explaining she did not consider Nairn should have been advised about myocarditis before being vaccinated.
But he needed to be advised to contact the pharmacy or his doctor if he developed symptoms after the vaccination, she said.
Information sheets in the booth did not list myocarditis as a side-effect, but did advise if a person experienced a "racing heart or chest pain" in the days after the vaccine, medical attention should be sought.
A search of Nairn's phone showed internet searches of "heart racing" and "myocarditis".
Coroner Johnson said she was satisfied she did not need to make any recommendations as the Health and Disability Commissioner (HDC) had carried out a thorough investigation.
Commissioner Morag McDowell said he should have been told about the rare but serious risk of myocarditis and to watch out for any symptoms as part of safety-netting advice.
While there was a breach of his right to be informed about the risks, she did not find the code had been breached.
"She considered that there were significant mitigating factors in this case, including that official information sources did not make it adequately clear to vaccinators that consumers needed to be told about myocarditis prior to receiving the vaccination," the report said.
But she noted that official guidance explicitly stated consumers must be advised about the symptoms, criticising the pharmacy for not picking this up and amending its processes.
"The commissioner was also critical that the vaccinating pharmacist
did not inform the consumer about myocarditis, and, in particular, the symptoms of myocarditis, as part of safety-netting advice," the report said.
McDowell noted the pharmacy had changed its practice since his death so the risk of myocarditis was specifically discussed.
She recommended that the pharmacy updated their informed consent processes and safety-netting advice for Covid-19 vaccines, sending their updated procedures to the commission within three months of the report.
She recommended Te Whatu Ora considered updating its guidelines to clarify when providers should discuss the risks and symptoms of myocarditis along with other side effects.
"Lessons can be learned from this case about the fundamental importance, in the context of new vaccines and emerging risks, of explicit guidance to vaccinators about what information they must give to consumers."
Te Whatu Ora said sincere efforts were made to obtain people's informed consent before administering the Covid-19 vaccine, but it accepted the Commissioner's findings.
Its National Public Health Service prevention acting national director Matt Hannant said Health New Zealand remained committed to ensuring vaccinators had the training and materials they needed to carry out their work
"We acknowledge the feedback received in the coronial inquest, and we will carefully review any feedback from the Royal Commission of Inquiry looking at lessons learned from New Zealand's response to Covid-19."
Severe Covid-19 vaccine side effects were rare, but on that regretful occasion, Nairn was not made aware of them, he said.
"During the Covid-19 pandemic, sincere efforts were made across the health system to equip our vaccinating workforce to immunise against Covid-19."
This included - and continued to include - discussing possible side effects before administering the vaccine.
"We continue to monitor the safety of all vaccines through collaboration and partnership across the health system," Hannant said.
"Our goal is to ensure New Zealanders are protected from preventable diseases and to make sure information about possible vaccine side effects is readily available.
"Being up to date with our vaccinations remains one of the best things we can do to protect ourselves from serious illness due to Covid-19."
'A small amount of closure'
Nairn's partner said she did no blame the pharmacy or pharmacist who administered the vaccine.
But Ashleigh Wilson said there was a profound grief and a lot of anger towards a system that had failed its people.
"The decision brings a small amount of closure, however it is disappointing that no one will be held accountable for such a needless death," she said.
She did not blame the pharmacy involved - which has name suppression - saying it was common practice for pharmacies not to advise consumers of heart-related side effects.
"The pharmacy was simply following the practices and protocols set out by ministry of health who unfortunately did not make clear the risks associated with the vaccination and that myocarditis could be a potential side effect," Wilson said.
"At the coronial inquest we saw no evidence from the official sources in any documents that stated myocarditis could be fatal and instead it was called 'rare and in most cases mild'."
Nairn would be missed every day for the rest of their lives, she said.
