There have been multiple conflicting claims made about the safety of the COVID-19 vaccines that were rolled out world-wide from Dec 2020. However, there is no universally agreed system for reporting either deaths or serious side-effects for which these vaccines may have been the cause or a contributory factor, and hence, as a result, there are concerns about variability in the quality of reports and the credibility of the sources submitting them. Reports can be submitted by physicians involved in administering the vaccine or helping treat side effects that may have consequentially arisen, clinical and non-clinical health service employees, or pharmaceutical professionals involved in the investigation. Likewise, lay people, such as the patient or their family and friends, may have submitted a report independently of medical carers. It has been suggested that a third category of submission may have been made by members of anti-vaccine, or other groups, motivated by ill-intent, who may exaggerate case numbers reported. Critics of safety reporting cite the fact that lay people, or those with malign intent, may form the bulk of reports and hence statistics on side effects must therefore be exaggerated because they come from non-credible sources. Set against this, research suggests that as few as 1% of the true adverse reactions ever get formally recorded.
In early April 2021 Scott McLachlan and colleagues downloaded the 2021 Vaccine Adverse Events Reporting System (VAERS) dataset (this is the US dataset) with the aim of analysing these reports to determine the range and frequency of health problems potentially caused by the vaccines as well as the quality of the reports and, by inference, the credibility of the reporters lodging them.
For each patient cited in a report, a clinically trained reviewer manually examined the report to determine its source and clinical credibility and to identify and record medical history, current illness, and symptoms. Each was then checked by a second reviewer. This process is ongoing, as there are 1644 deaths in the April VAERS deaths dataset that have been reported in patients who had recently received their first or second COVID-19 vaccination, and over 28,000 serious adverse events that did not result in death.
McLachlan and colleagues have today published an interim report that presents the results of their analysis of the first 250 reported deaths that have been reviewed and coded by the team.
They identified health service employees as the reporter in at least 67% of the reports, while pharmaceutical employees were identified as the reporter in a further 5%. Lay people were identifiable as the reporter in only 28% of the reports. This suggests an intention for clinical applicability and usefulness and goes some way towards addressing the common disclaimer that many VAERS reports are made by aggrieved family members and anti-vaxxers, both with an axe to grind.
With regard to analysing the likely role of the vaccine in the reported deaths, the sample is heavily biased because these were all people vaccinated very early in the programme when only the elderly, those with significant or chronic health conditions and frontline health service staff were being vaccinated. The analysis shows that the patients can be grouped into three main types:
- those where the vaccine was most likely not a factor;
- those where the vaccine may have been a factor; and
- those where the vaccine was the most likely factor in their deaths.
Despite the sample bias, they found that in 34 of the 250 deaths (14%) a vaccine reaction could be ruled out as a contributing factor in their death; these were all patients either already bedridden and expected to die from a serious medical condition like lung cancer, or were described as at end of life or receiving palliative hospice care. For 203 of the 250 (81%) the vaccine may have been a factor in their death; however, many of these patients had one or more chronic or age-related comorbid conditions. Finally, for at least 13 of the 250 deaths (5%) the vaccine was the most likely cause of death; these patients had strong reactions soon after vaccination and died either on the same day, or during the next couple of days.
The full report:
McLachlan, S, Osman, M, Dube, K, Chiketero, P, Choi, Y, and Fenton N (2021) "Analysis of COVID-19 vaccine death reports from the Vaccine Adverse Events Reporting System (VAERS) Database", http://dx.doi.org/10.13140/RG.2.2.26987.26402
See also:The problem with ALL studies so far into the risks and/or benefits of Covid-19 vaccines