Reporting rates for VAERS death reports following COVID ‐19 vaccination, December 14, 2020–November 17, 2021

  1. Brendan Day
  2. David Menschik
  3. Deborah Thompson
  4. Christopher Jankosky
  5. John Su
  6. Pedro Moro
  7. Craig Zinderman
  8. Kerry Welsh
  9. Rositsa B. Dimova
  10. Narayan Nair

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Abstract

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.

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  1. Version published to 10.1002/pds.5605
  2. ScreenIT

    SciScore for 10.1101/2022.05.05.22274695: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsIRB: Ethics: Because VAERS is a vaccine safety surveillance program, this study was exempt from Institutional Review Board review.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    No key resources detected.

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Our study also has limitations. First, VAERS reports can have conflicting or missing information, which could impact the results. For example, for one of our analyses (Table 2), 1,024 death events were excluded due to invalid or missing information regarding time to onset. However, we aimed to reduce the effect of missing or conflicting information in VAERS reports by using a standard set of consolidation rules (Table S1) to capture death events and their characteristics (age, sex, and time to onset); even so, these rules could yield inaccurate values. For example, age may be captured inaccurately if a healthcare provider reports the age inaccurately, despite a family member separately reporting the correct age. Second, although this analysis demonstrates low reporting rates of death after vaccination overall, these data do not preclude causal attribution of the vaccine for verified safety signals of specific adverse events. For example, an earlier review of VAERS reports for Ad26.COV2.S vaccine identified a safety signal for thrombosis with thrombocytopenia syndrome (TTS), a rare and serious adverse event that causes blood clots with low platelets. Further evaluation of this safety signal confirmed a causal relationship, and as of December 16, 2021, nine deaths reported in VAERS had been directly attributed to TTS following Ad26.COV2.S vaccine (32). Another potential limitation includes underreporting in VAERS. Underreporting is a well-known limitation of all passive surveil...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

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  3. Version published to 10.1101/2022.05.05.22274695v1 on medRxiv