Answered on December 24, 2024
The number of deaths reported following COVID-19 vaccination has been a subject of extensive monitoring and analysis. According to the Vaccine Adverse Event Reporting System (VAERS) data, between December 14, 2020, and November 17, 2021, there were 9,201 death events reported for COVID-19 vaccine recipients aged 5 years and older. However, it is important to note that the reporting rates for these death events were lower than the expected all-cause death rates in the general population, suggesting no association between vaccination and overall increased mortality.[1]
Additionally, a study analyzing data from Qatar found that among 6,928,359 doses administered, only eight deaths had a high probability of being related to the vaccine, translating to a rate of 1.15 deaths per million doses.[2] Another study from the United States reported 4,496 deaths out of 298,792,852 doses of mRNA vaccines administered, with most adverse events being mild and short in duration.[3]
In summary, while deaths have been reported following COVID-19 vaccination, the data indicate that these events are extremely rare and often not causally related to the vaccine. The benefits of vaccination in preventing COVID-19 far outweigh the risks of these rare adverse events. The number of deaths reported following COVID-19 vaccination is 9,201 in the United States as per VAERS data, but these are not necessarily causally linked to the vaccine.

1.
Reporting Rates for VAERS Death Reports Following COVID-19 Vaccination, December 14, 2020-November 17, 2021.

Day B, Menschik D, Thompson D, et al.

Pharmacoepidemiology and Drug Safety. 2023;32(7):763-772. doi:10.1002/pds.5605.

Purpose: Despite widely available safety information for the COVID-19 vaccines, vaccine hesitancy remains a challenge. In some cases, vaccine hesitancy may be related to concerns about the number of reports of death to the Vaccine Adverse Event Reporting System (VAERS). We aimed to provide information and context about reports of death to VAERS following COVID-19 vaccination.

Methods: This is a descriptive study evaluating reporting rates for VAERS death reports for COVID-19 vaccine recipients in the United States between December 14, 2020, and November 17, 2021. Reporting rates were calculated as death events per million persons vaccinated and compared to expected all-cause (background) death rates.

Results: 9201 death events were reported for COVID-19 vaccine recipients aged 5 years and older (or age unknown). Reporting rates for death events increased with increasing age, and males generally had higher reporting rates than females. For death events within 7 days and 42 days of vaccination, respectively, observed reporting rates were lower than the expected all-cause death rates. Reporting rates for Ad26.COV2.S vaccine were generally higher than for mRNA COVID-19 vaccines, but still lower than the expected all-cause death rates. Limitations of VAERS data include potential reporting bias, missing or inaccurate information, lack of a control group, and reported diagnoses, including deaths, are not causally verified diagnoses.

Conclusions: Reporting rates for death events were lower than the all-cause death rates expected in the general population. Trends in reporting rates reflected known trends in background death rates. These findings do not suggest an association between vaccination and overall increased mortality.

2.
Evaluation of Mortality Attributable to SARS-CoV-2 Vaccine Administration Using National Level Data From Qatar.

Butt AA, Guerrero MD, Canlas EB, et al.

Nature Communications. 2023;14(1):24. doi:10.1038/s41467-022-35653-z.

Leading Journal

Accurate determination of mortality attributable to SARS-CoV-2 vaccination is critical in allaying concerns about their safety. We reviewed every death in Qatar that occurred within 30 days of any SARS-CoV-2 vaccine administration between January 1, 2021 and June 12, 2022. Probability of association with SARS-CoV-2 vaccination was determined by four independent trained reviewers using a modified WHO algorithm. Among 6,928,359 doses administered, 138 deaths occurred within 30 days of vaccination; eight had a high probability (1.15/1,000,000 doses), 15 had intermediate probability (2.38/1,000,000 doses), and 112 had low probability or no association with vaccination. The death rate among those with high probability of relationship to SARS-CoV-2 vaccination was 0.34/100,000 unique vaccine recipients, while death rate among those with either high or intermediate probability of relationship to SARS-CoV-2 vaccination was 0.98/100,000 unique vaccine recipients. In conclusion, deaths attributable to SARS-CoV-2 vaccination are extremely rare and lower than the overall crude mortality rate in Qatar.

3.
Safety of mRNA Vaccines Administered During the Initial 6 Months of the US COVID-19 Vaccination Programme: An Observational Study of Reports to the Vaccine Adverse Event Reporting System and v-Safe.

Rosenblum HG, Gee J, Liu R, et al.

The Lancet. Infectious Diseases. 2022;22(6):802-812. doi:10.1016/S1473-3099(22)00054-8.

Leading Journal

Background: In December, 2020, two mRNA-based COVID-19 vaccines were authorised for use in the USA. We aimed to describe US surveillance data collected through the Vaccine Adverse Event Reporting System (VAERS), a passive system, and v-safe, a new active system, during the first 6 months of the US COVID-19 vaccination programme.

Methods: In this observational study, we analysed data reported to VAERS and v-safe during Dec 14, 2020, to June 14, 2021. VAERS reports were categorised as non-serious, serious, or death. Reporting rates were calculated using numbers of COVID-19 doses administered as the denominator. We analysed v-safe survey reports from days 0-7 after vaccination for reactogenicity, severity (mild, moderate, or severe), and health impacts (ie, unable to perform normal daily activities, unable to work, or received care from a medical professional).

Findings: During the study period, 298 792 852 doses of mRNA vaccines were administered in the USA. VAERS processed 340 522 reports: 313 499 (92·1%) were non-serious, 22 527 (6·6%) were serious (non-death), and 4496 (1·3%) were deaths. Over half of 7 914 583 v-safe participants self-reported local and systemic reactogenicity, more frequently after dose two (4 068 447 [71·7%] of 5 674 420 participants for local reactogenicity and 4 018 920 [70·8%] for systemic) than after dose one (4 644 989 [68·6%] of 6 775 515 participants for local reactogenicity and 3 573 429 [52·7%] for systemic). Injection-site pain (4 488 402 [66·2%] of 6 775 515 participants after dose one and 3 890 848 [68·6%] of 5 674 420 participants after dose two), fatigue (2 295 205 [33·9%] participants after dose one and 3 158 299 participants [55·7%] after dose two), and headache (1 831 471 [27·0%] participants after dose one and 2 623 721 [46·2%] participants after dose two) were commonly reported during days 0-7 following vaccination. Reactogenicity was reported most frequently the day after vaccination; most reactions were mild. More reports of being unable to work, do normal activities, or of seeking medical care occurred after dose two (1 821 421 [32·1%]) than after dose one (808 963 [11·9%]); less than 1% of participants reported seeking medical care after vaccination (56 647 [0·8%] after dose one and 53 077 [0·9%] after dose two).

Interpretation: Safety data from more than 298 million doses of mRNA COVID-19 vaccine administered in the first 6 months of the US vaccination programme show that most reported adverse events were mild and short in duration.

Funding: US Centers for Disease Control and Prevention.