Man who succumbed to vaccine-induced myocarditis did not receive information on potential side effects

A New Zealand man who died from heart inflammation induced by a COVID-19 vaccine was not informed that inflammation was a possible side effect of the shot, according to health authorities.

The young man, in his 20s, also was not warned of symptoms linked to the inflammation, such as chest pain.

The man received a Pfizer-BioNTech vaccine at a pharmacy in New Zealand in late 2021. The man began experiencing chest discomfort and heart palpitations but did not seek medical attention because he did not know these symptoms could be related to the vaccine, according to New Zealand Health and Disability Commissioner Morag McDowell.

At approximately 3:30 a.m., 12 days after receiving the vaccine, the man collapsed and died. A coroner found the cause of death was myocarditis, or heart inflammation, and that the myocarditis was caused by the vaccine.

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Leaflets for vaccine recipients stated in part: “There are some side effects that are more serious but very rare, like a severe allergic reaction or an inflammation of the heart. If you develop difficulty breathing, a racing heart, chest pain or feel faint immediately after or in the days after the vaccine, you should seek medical attention.”

Updated fact sheets for health care professionals outlined symptoms of myocarditis and said people should be told to seek medical attention if they experienced certain symptoms. Ministry of Health guidance also said workers must tell people to seek medical advice for any “unexpected concerns,” including chest pain, shortness of breath, or palpitations.

The pharmacy that administered the vaccine to the man received forms that included the requirement but directed workers to only go over common side effects for Pfizer’s vaccine, not the rarer ones. The pharmacy operations manager told investigators it would be unusual to advise consumers of every side effect of a medication. The manager said workers who vaccinated people offered a leaflet to the recipients but did not “force it on them.”

The manager said she was not aware that authorities determined in August 2021 that a New Zealand woman died from vaccine-induced myocarditis.

The pharmacist who injected the man said she typically went over common side effects but did not go over myocarditis. She said she was aware heart inflammation was a side effect of the vaccine but was not informing recipients because it was “a very rare side effect of the vaccine.” She said that the operations manager never told workers to inform people of myocarditis or symptoms that could be related to it.

“The practice at the pharmacy at the time of Mr. A’s vaccination was inadequate to satisfy the obligation to provide the information that a reasonable consumer would expect to receive (being information about myocarditis), both prior to vaccination and post-vaccination,” the report on the investigation stated.

Identifies Breach of Rights

The commissioner identified a “prima facie breach” of the New Zealand Code of Rights, which says that “Every consumer has the right to the information that a reasonable consumer, in that consumer’s circumstances, would expect to receive,” including “an assessment of the expected risks, side effects, benefits, and costs of each option.”

At the same time, Ms. McDowell said that authorities “did not make it adequately clear to vaccinators that consumers needed to be told about myocarditis prior to receiving the vaccination.” The email communicating the guidance that said vaccinators must describe symptoms of myocarditis did not itself refer to myocarditis or highlight what the guidance covered, making it less likely pharmacies would understand its significance, according to the commissioner.

“I am also mindful that the Comirnaty vaccine was, at the time, relatively new and new information about its use, risk and side effects was still forthcoming. While consumers’ rights to informed consent under the code are of fundamental importance, and I am very concerned that it appears that Mr. A’s right to the information that he was entitled to receive was not upheld, the unique and novel situation leads me to conclude that it would be disproportionately harsh to find a breach, and that an educational approach is more appropriate in the circumstances,” Ms. McDowell said. “I am also mindful of guarding against hindsight bias.”

The commissioner also chose not to find the pharmacist who administered the vaccine in breach of the code, because her not informing Mr. A about myocarditis or its symptoms was “materially mitigated by the deficiencies in guidance from official sources and the pharmacy.”

In cases where breaches are found, penalties such as damages can be levied. Providers are also usually named if they’re found in breach.

The commissioner issued a range of recommendations, including suggesting the Ministry of Health be more clear in guidance about side effects in the future. The pharmacy started informing people about the risk of myocarditis after Mr. A died, according to the report.

The pharmacy and vaccinator were not identified and declined to comment to the commissioner. The Ministry of Health responded to a request for comment from The Epoch Times but declined to immediately provide a statement on the report. Health officials told Ms. McDowell that they believe they properly communicated the risk of myocarditis to vaccination providers. Pfizer has not responded to recent requests for comment about myocarditis.

Ashleigh Wilson, Mr. Nairn’s fiancee, told news outlets in a statement that the commissioner’s decision “brings a small amount of closure.”

“However, it is disappointing that no one will be held accountable for such a needless death,” she added, “and Rory will be missed every day for the rest of our lives.”