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COVID-19 vaccine did not cause or contribute to death of 46-year-old woman: Coroner

SINGAPORE: A 46-year-old woman who died four days after receiving a COVID-19 vaccine had died of natural causes and her death is not caused or contributed to by the Pfizer-BioNTech/Comirnaty mRNA vaccine, a coroner's court has found.

In findings made available this week, State Coroner Adam Nakhoda found that Ms Leong Jeng Fun had died of ischaemic heart disease.

Ms Leong, a bank teller who lived with her parents, had gone to Teck Ghee Community Centre on the morning of Dec 26, 2021, to receive her third dose of the COVID-19 vaccine.

She was monitored for the standard period of time before she headed home.

About two hours later, she texted her sister saying she was feeling "very heavy". Her father later found her sleeping on the floor, a usual practice for her, but could not wake her up.

Ms Leong's sister called the Singapore Civil Defence Force at about 2.40pm saying her sister appeared to be not feeling well after receiving her booster.

Paramedics found that Ms Leong was not breathing and commenced cardiopulmonary resuscitation, which they continued while taking her to Sengkang General Hospital (SKGH).

She was found to have suffered an "out-of-hospital cardiac arrest with a downtime of 77 minutes". Despite medical intervention, she could not be revived. 

After extensive discussions with the family, it was decided that Ms Leong would not be resuscitated. She died at 2.26am on Dec 30, 2021.

The hospital reported the case to the police, citing a death with an unknown manner or cause.

An autopsy found that her final cause of death was ischaemic heart disease, with the medical officer who performed the autopsy noting that Ms Leong's heart showed severe coronary artery disease with bleeding in the heart.

At the coroner's inquiry, Ms Leong's sister said that it was "highly possible that there was a connection between the vaccine and her sister's death, due to the proximity in time.

She pointed out a note in SKGH's discharge summary, which stated that her sister was allergic to tozinameran, which is found in the vaccine.

EXPERT ADDRESSES POSSIBLE LINKS TO VACCINE

Dr Tan Sze-Chin, a senior consultant at Tan Tock Seng
Hospital's Department of Rheumatology, Allergy, and Immunology, was appointed by the Academy of Medicine Singapore to provide an expert report on Ms Leong’s death. 

He considered the possibilities that Ms Leong's death had been due to anaphylaxis - a dangerous allergic reaction - or myocarditis - inflammation of the heart - because of the COVID-19 vaccine.

Dr Tan first eliminated the possibility of anaphylaxis, saying there was a delayed onset from the time of vaccination to the time of collapse, and none of the usual signs such as flushing, swelling or rash.

Dr Tan said myocarditis associated with the COVID-19 vaccine typically occurs within two weeks of the vaccination, commonly within three to four days of the jab.

He cited publications which stated that vaccine-related myocarditis tends to occur in men, with the majority of cases following the second dose. 

Dr Tan said there had been no reports of sudden cardiac arrest following vaccination, and noted that Ms Leong had a family history of sudden cardiac death.

She also had risk factors such as high cholesterol and was noted to be obese, said Dr Tan.

He explained that the hospital had labelled Ms Leong as being allergic to tozinameran because her managing physicians at the time were not able to exclude the possibility that she had suffered an adverse reaction to the vaccine.

Before this entry, there were no entries in her medical records of drug allergies, said Dr Tan.

Based on the information he received, Dr Tan concluded that Ms Tan's collapse and death were not related to the COVID-19 vaccine.

Dr Mandy Lau, who conducted the autopsy, ordered investigations to determine if Ms Leong's death was a result of the vaccine.

She noted no evidence of anaphylaxis such as swelling to her face, eyes or mouth, or mucous plugging in her lungs.

Certain enzyme levels that are markers of anaphylaxis were within the normal range, Dr Lau found.

Analysis of Ms Leong's heart tissue also did not reveal any evidence of myocarditis, but did reveal changes consistent with ischaemic heart disease.

INFORMATION FROM HSA

The coroner cited the Health Sciences Authority's status updates, which provide overviews of the reports by healthcare professionals of suspected "adverse events" to the COVID-19 vaccines.

This refers to "any untoward medical occurrence in a patient (who is) administered a pharmaceutical product (including vaccines) but does not necessarily have a causal relationship with this treatment/vaccination".

HSA emphasised in its 10th status update that adverse events reported "do not necessarily mean that the vaccine had caused the adverse event, as the adverse events may have been related to an underlying or undiagnosed disease or the natural progression of an underlying disease".

"In other words, it may be coincidental that an event occurred when or shortly after the vaccine was given but that event was not caused by the vaccine," said HSA.

As of Dec 31, 2022, a total of 10.5 million doses of mRNA COVID-19 vaccinations had been administered in Singapore. The reporting rate for adverse events remained rare at 0.11 per cent, or 17,741 reports, and 0.007 per cent or 1,119 reports for serious adverse events, said the coroner.

The most commonly reported adverse events included allergic reactions, dizziness, shortness of breath, chest discomfort, and muscle ache, which generally resolved within a few days.

HSA pointed out that the reporting rate of serious adverse events for the mRNA vaccines of 0.006 per cent of doses administered was "relatively stable".

Of the serious adverse events for mRNA vaccines, the most frequently reported were anaphylaxis and other allergic reactions.

HSA said these were being closely monitored and that background disease incidents or underlying medical conditions were taken into consideration when determining if the vaccine had any contributory role.

HSA's safety updates highlighted that heart attacks and strokes occur naturally within the population, regardless of whether people are vaccinated.

"Due to the large number of people being vaccinated, it was expected that, by coincidence, some individuals may experience other medical events, such as heart attacks and strokes in the days or weeks after vaccination, which may not be related to the vaccination," said HSA in its safety updates cited by the coroner.

HSA said it was continuing to monitor these events closely and would update the public if there were significant findings, such as a link between vaccination and heart attacks or strokes.

The coroner said Ms Leong had a medical history of schizophrenia and high cholesterol and was not always compliant with her psychiatric medication despite being on medication for both conditions.

He found that there was no evidence to suggest that Ms Leong suffered from any adverse effects following her two earlier vaccinations.

"I would emphasise HSA's safety updates that heart attacks and strokes occur naturally within the population," said the State Coroner.

"This is regardless of whether they have been vaccinated. Due to the large numbers of people being vaccinated, it has to be expected that there may be deaths where a person passes away from natural causes shortly after receiving the COVID-19 vaccination."

In order to establish that the vaccine was implicated in a person's death, there would have to be evidence of the link in terms of both clinical symptoms and evidence at autopsy, said the coroner.

In this case, there was no such evidence, so he concluded that the vaccine did not cause or contribute to Ms Leong's death.

He extended his condolences to her family for their loss.