One Report of Heart or Lung Issue Per 45 Doses of COVID Vaccine: Study

Research also shows one adverse effect that prevented daily activities or needed medical care per 17 doses administered

People wait in line at the Palais des congres vaccination site in Montreal on June 6, 2021. The Canadian Press/Graham Hughes

Data collected in a study on COVID-19 vaccination side effects shows that for every 45 doses administered, there was one self-report of a symptom affecting the cardiorespiratory system, such as heart palpitations, chest tightness or pain, or breathing difficulty.

The results of the study were published in March in the journal Clinical Infectious Diseases by researchers from the government-funded Canadian National Vaccine Safety (CANVAS) Network.

The study centred on adverse events among adults with a prior history of moderate or severe infection from SARS-CoV-2—the virus that causes COVID-19—before being vaccinated for the infectious disease.

The researchers collected data from adults with or without a prior infection, and found that those in the group with a prior infection were “more likely to have a health event sufficient to impact routine activities or require medical assessment in the week following each vaccine dose.”

The data was collected by sending a survey to participants eight days after they received each of their first, second, and third doses, requesting information about their health status in the previous seven days.

CANVAS researchers provided the survey results in their journal article, detailing every kind of side effect reported and the ensuing consequences.

Those consequences were categorized under health events that “prevented daily activities or required medical care,” including events that resulted in an emergency department visit or hospitalization.

Results show 66,151 events that prevented daily activities or required medical care for 1,173,748 doses administered, or 1 event per 17 doses (5.64 percent of all doses administered and surveyed for the study, a rate of 5,636 per 100,000 doses).

Side Effects Involving Heart, Breathing, Nervous System

The Epoch Times analyzed the data to determine the number of doses linked to side effects and to compare it with figures provided by the Public Health Agency of Canada (PHAC).

The raw numbers were not evaluated against a control group, which would show a baseline for the reporting of certain symptoms or hospital visits. Also other confounding factors that could have impacted the survey results were not explored.

In total there were 870,516 side effects reported to CANVAS out of 1,173,748 doses surveyed. The most common side effect reported was injection-site reactions, with over half of doses (620,757) resulting in a report.

But the study also documented side effects that are potentially more serious, affecting neurological and cardiorespiratory systems.

Across vaccine types, including Pfizer’s BNT162b2, Moderna’s mRNA-1273, and AstraZeneca’s ChAdox1-S, and for all doses, there were 25,905 events of people self-reporting cardiorespiratory issues, or one event per 45 doses.

Specifically, the 25,905 cardiorespiratory events consisted of 6,103 reports of heart palpitations (1 per 192 doses), 7,175 reports of chest tightness/pain (1 per 164 doses), 6,104 reports of difficulty in breathing (1 per 192 doses), and 6,523 reports of coughing (1 per 180 doses).

It has been established that COVID-19 vaccination can cause heart damage, such as myocarditis, or inflammation of the heart muscle, but health authorities maintain that such events are “rare.”

A recent study published in the European Journal of Heart Failure found that 1 in 35 health-care workers at a Swiss hospital had signs of heart injury after receiving a booster dose of Moderna’s mRNA-1273 vaccine.

CANVAS data also indicates there were 73,006 neurological adverse events reported, such as headache or migraine, dizziness or vertigo, loss of taste or smell, inability to walk, and loss of vision. There were 2,795 events of people reporting being unable to walk after vaccination and 691 who experienced loss of vision.

PHAC vs. CANVAS

These numbers of adverse events are much higher than what PHAC reports. Based on data up to and including May 26, the agency said it had received individual reports from 55,145 people each of whom reported one or more adverse events following immunization. This is 0.056 percent of the total 98,194,601 COVID-19 vaccine doses administered.

PHAC acknowledges that its surveillance system is “passive” and “suffers from underreporting,” and that it relies on projects like CANVAS to gain a better picture of vaccine safety.

PHAC’s system depends on health-care professionals in the provinces and territories directly reporting the adverse events to the agency, but those professionals may not report the events, or patients may not report the events to their health-care providers.

On the other hand, the CANVAS study is based on self-reporting, without review of medical charts. The study does note that a staff member trained in eliciting information on adverse events will phone to follow up on reports of events that resulted in a medical visit.

PHAC and Health Canada spokesperson Nicholas Janveau says that both health authorities have reviewed the CANVAS data and that the findings align with theirs. He adds that the study results have also been included in the monograph of each brand of COVID-19 vaccine.

Mr. Janveau noted that there are similarities between PHAC’s reports of “serious” adverse events and CANVAS’s reports of hospitalizations.

PHAC reports 10,906 serious events for the total 98,194,601 doses administered, at a rate of 11.1 per 100,000 doses. Serious events include deaths and situations that are life-threatening or require hospitalization.

The CANVAS study reported 136 events resulting in hospitalization for the total 1,173,748 doses surveyed, at a rate of 11.58 per 100,000 doses.

“This is slightly higher but is within the same order of magnitude,” said Mr. Janveau.

Different Picture

A different picture emerges when broadening the scope to include all side effects that led people to seek medical attention.

CANVAS data showed 13,455 medically attended events within seven days post-vaccination, or 1,146.3 per 100,000 doses, along with 3,140 emergency department visits, or 267.5 per 100,000 doses.

These events don’t necessarily indicate causality, Mr. Janveau noted.

“Reports of adverse events following immunization, including reports with serious outcomes, do not necessarily imply a relationship between the adverse event and the vaccine,” he said. “However, they are an important information source supporting ongoing safety monitoring.”

The CANVAS seven-day assessment period is a short window, as the provinces have a temporal criteria of up to 42 days to monitor for certain types of adverse events following immunization.

Health Canada and PHAC maintain that “the benefits of COVID-19 vaccines continue to outweigh the risks of the disease.”

The Epoch Times contacted CANVAS and its lead researcher for comment but didn’t hear back by press time.

The CANVAS study concluded, “Providers should consider additional vaccine counselling on expected adverse effects for individuals previously infected with SARS-CoV-2 prior to vaccination.”