The Health and Disability Commissioner has released a report on the death of a man from myocarditis, which was found by the Coroner to have been directly caused by the Pfizer COVID-19 vaccine.
Commissioner Morag McDowell found the man, aged in his twenties, was informed of the common vaccine side effects but not the potentially serious ones including myocarditis.
The man received his COVID-19 vaccine in 2021 and afterwards reported feeling chest discomfort and heart flutters.
According to the report, he was apparently unaware that myocarditis (inflammation of the heart) was a potentially serious side effect of the vaccine.
The man experienced the symptoms for 12 days before he decided to go to the hospital. But he collapsed and died before he could.
Commissioner McDowell said the failure to inform the man about the potential serious side effects of the vaccine, including myocarditis, was a prima facie breach of the Code of Health and Disability Services Consumers’ Rights (the Code).
The Commissioner said she was satisfied official agencies intended for the risk of myocarditis to be communicated to consumers as part of the consent process and that consumers were expected to be given safety-netting advice about myocarditis symptoms following their vaccination.
However, she concluded that, in light of significant mitigating factors, it would be disproportionately harsh to find the pharmacy in breach of the Code, and that an educational approach was more appropriate.
McDowell noted when the man was vaccinated, the vaccine was "relatively new and new information about its use, risk and side effects was still forthcoming".
The broader public context was also relevant for this case, she said, noting it took place during "the unprecedented international and national response prompted by the pandemic which was accompanied by a concurrent steady flow of information from official sources".
However, she found that none of the sources of official information explicitly required vaccinators to disclose the risk of myocarditis as part of the informed consent process before vaccination.
She also noted there was evidence that the importance of new information, relative to other information, was not made clear to vaccination providers.
"Given the seriousness of the risk of myocarditis and the information volume, one could reasonably expect that in communication to the providers, the risk would be emphasised or highlighted in some way," she said.
While she did not find the pharmacy in breach of the Code, McDowell was critical that it did not update its standard operating procedure to ensure consumers were given adequate safety netting advice about the risk of the symptoms of myocarditis to look out for.
She also made an adverse comment about the pharmacist who vaccinated the man, but similarly did not find her in breach due to the mitigating factors outlined.
McDowell made an educational comment to Manatū Hauora│Ministry of Health, stating that, in relation to the Comirnaty vaccine it needed to provide clear and unambiguous guidance to vaccinating providers about what and when they needed to tell consumers about myocarditis.
This was particularly relevant following the first death in New Zealand from myocarditis following the Comirnaty COVID-19 vaccine, which occurred before the man's death.
McDowell made several recommendations for both the pharmacy and Te Whatu Ora, including:
The pharmacy updates its standard operating procedures to include a separate section about COVID-19 vaccines, the informed consent process and required safety-netting advice.
The pharmacy sends a copy of its updated procedures to the Health and Disability Commissioner within three months of the date of this report. 94.
Noting that the NIP is now part of Te Whatu Ora, rather than Manatū Hauora, 24 McDowell recommended that Te Whatu Ora consider updating its Operating Guidelines to clarify at what point(s) in the process25 providers should discuss the risk and symptoms of myocarditis, as well as any other side effects, when consumers are receiving the Comirnaty vaccine.
Te Whatu Ora is to report back to HDC on the results of its consideration, including details of any updates to its Operating Guidelines, within three months of the date of this report.
