Science, Public Health Policy,
and The Law
Volume 2:59–80
May, 2021
Clinical and Translational
Research

An Institute for Pureand Applied Knowledge (IPAK)
Public Health Policy
Initiative (PHPI)

A Report on the U.S. Vaccine Adverse Events
Reporting System (VAERS) of the COVID-1 9
Messenger Ribonucleic Acid (mRNA) Biologicals

Jessica Rose, PhD, MSc, BSc

Abstract

Following the global roll-out and administration of the Pfizer/BioNTech (BNT1 62b2) andModerna (mRNA-1 273) COVID-1 9 vaccines 1 on December 1 7, 2020 in the United States,and of the Janssen COVID-1 9 Vaccine PF (produced by Johnson & Johnson) on April 1 st,
2021 , tens of thousands of individuals have reported adverse events (AEs) using the
Vaccine Adverse Events Reports System (VAERS). This work summarizes this data todate and serves as information for the public and a reminder of the relevance of any
adverse events, including deaths, that occur as a direct result of biologicals as
prophylactic treatments. This is especially relevant in the context of technologically novel
treatments in the experimental phase of development. Analysis suggests that the vaccines
are likely the cause of reported deaths, spontaneous abortions, anaphylactic reactions
and cardiovascular, neurological and immunological AEs. The precautionary principle
promotes transparency and the adoption of preventative measures to address potential
risks to the public in the arena of vaccination programs, and it is vital that individuals are
informed of these potential risks before agreeing to participate in any medically involved
treatment program. VAERS reporting and recording is essential to the proper functioningof this system. It cannot be over-emphasized that the public should know how to use thissystem such that they actually do use it, and that once reports are made, responsible
individuals enter each report into the database accordingly.
Copyright © The Author — Creative Commons License (https://creative commons.org/licenses/)

Author affiliation: The Institute for Pure and Applied Knowledge
Correspondence: jrose@ipaknowledge.org

Keywords

VAERS (Vaccine Adverse Event Reporting System), AE (Adverse Event), SAE (Severe
Adverse Event), COVID-1 9 (Corona Virus Disease 201 9)
1 mRNA biologicals are not true vaccines. True vaccines are a preparation of a weakened or killed

pathogen, such as a bacterium or virus, or of a portion of the pathogen's structure that, uponadministration to an individual, stimulates antibody production or cellular immunity against thepathogen but is incapable of causing severe infection. Vaccines undergo an extremely rigorous timedependent testing protocol to ensure safety and efficacy, typically enduring between 1 0 and 1 5 years.
The mRNA biologicals do not satisfy either of these requirements and are thus more akin toexperimental treatments.

Sci, Pub Health Pol, & Law

VAERS Report on COVID-19 mRNA Biologicals – May, 2021
that may be associated with vaccines. Most
vaccine adverse event reports concern relatively
minor events, such as injection site pain. Other
reports describe serious events, such as
hospitalizations, life-threatening illnesses, ordeaths.[1] The reports of serious events are ofgreatest concern and are meant to receive themost careful scrutiny by VAERS staff andhealthcare professionals. The primary purpose ofmaintaining the database is to serve as an early
warning or signaling system for adverse events
not detected during pre-market testing. In
addition, the National Childhood Vaccine Injury
Act of 1986 (NCVIA) requires healthcare
providers and vaccine manufacturers to report to
the DHHS specific adverse events following theadministration of those vaccines outlined in theAct.[1] It must be noted that the adverse events
reported to VAERS represent a fraction of theactual number of incidents. Studies have shownthat the percentage of incidents reported can bequite low (1–10%) but, for the purposes of thisreport, in order to do the necessary calculations,
VAERS numbers were used and the results
should be considered to reveal trends.[1,2]Contents
1
2

3

4
5

Background
Methods
1

General methodology anddescriptive statistics

2

Statistical testing and causation

1

General information

62
63
63
63

1.1

Incidence rates of AE groups per
VAERS IDs64

1.2

Incidence rates of AE groups per
fully vaccinated population

65

2

Distribution of data:
Age association with vaccineassociated AEs

66

2.1

Deaths, hospitalizations andER visits

67

2.2

Cardiovascular, neurological andimmunological events

2.3

Anaphylactic reactions

2.4

Spontaneous abortions

3

Evidence to support causation

4

Confirmed COVID-19 cases
post-vaccination

Results

Discussion
Conclusion
Funding and Conflicts of Interest
Information

6
7

57
62

References
Supplementary Figures

67
68
68
69

An Adverse Event (AE) is defined as any
untoward or unfavorable medical occurrence in ahuman study participant, including any abnormal
physical exam or laboratory finding, symptom,
or disease, temporally associated with theparticipants’ involvement in the research, whether
or not it is considered related to participation in
the research. A Serious or Severe Adverse Event(SAE) is defined as any adverse event that resultsin death, is life threatening, or places theparticipant at immediate risk of death from theevent as it occurred, requires or prolongs
hospitalization, causes persistent or significant
disability or incapacity, results in congenital
anomalies or birth defects, or is another condition
which investigators judge to represent significant
hazards.2,3 The VAERS handbook states that

71
72
73
74
74
78

1 . Background
The Vaccine Adverse Event Reporting System(VAERS) was created and implemented in 1990
by the Food & Drug Administration (FDA) andCenters for Disease Control and Prevention(CDC) to receive reports about adverse events

2 National Institute on Aging. Adverse Event and Serious Adverse Event Guidelines.

https://www.nia.nih.gov/sites/default/files/2018-09/nia-ae-and-sae-guidelines-2018.pdf [40]3 FDA. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?frexternal%20icon
60

Sci, Pub Health Pol, & Law

VAERS Report on COVID-19 mRNA Biologicals – May, 2021

approximately 15% of reported AEs are classified
as severe.[1]Ongoing collection of data in systems such
as VAERS in the United States, the Coronavirus
Yellow Card reporting site for the United
Kingdom, as well as independent reports of AEs,
merits further examination into both the safety andefficacy of the mRNA vaccines currently beingrolled-out globally in response to COVID-19, inparticular those designed by Pfizer/BioNTech(BNT162b2, now known as the Pfizer-BioNTech
COVID-19 Vaccine) and Moderna (mRNA-1273),
which have been the most widely administered.4
mRNA platforms are new in medical
microbiology and have never before been
implemented for use in human subjects on a
global scale in the context of viruses. Safety isalways a point of relevance with regards to new
biological agents. As stated, the primary purpose
for maintaining the VAERS database is to serveas an early warning system and one should becautious in drawing conclusions regarding safety
in its context. But since the number and range ofside effects is vast and no long-term data ofpotential damaging effects such as autoimmune
reactions exists, AE collection systems such asthese are of utmost importance, not only to flag
potential severe AEs not detected during premarket testing but also for weighing in on thepotential safety of the biologicals themselves.
The efficacy of a conventional vaccine ismeasured via explicit demonstration of broadspectrum potent immune responses in the formsof both cellular and humoral responses as well as
the establishment of enduring immunity.[3–7]Although there are some studies claiming
efficacy for these mRNA biologicals in humans,[4,5] that efficacy is not based on immunological assessment but rather on clinical assessment
based on primary and secondary endpoints
including confirmed or severe COVID-19. In
these same studies, safety is assessed based on a
maximum observation period of six months. This
is not adequate to assess long-term safety
outcomes. In this context, it is worth noting that
the Pfizer/BioNTech, Moderna, and Janssen
COVID-19 vaccines have not been approved or
licensed by the FDA, having been authorized
instead for emergency use by the FDA under an
Emergency Use Authorization (EUA) to prevent
Coronavirus Disease 2019 (COVID-19), for use
in individuals 16 years of age and older.[8–10]
Ultimately, the roll-out of COVID-19 vaccines is
actively being monitored, but all of the risks are
not yet known.[9,10] In spite of this, real-world
trials and administration of these biologicals into
pregnant women and children are being pursued
in countries around the world, such as Israel.[11]The VAERS dataset is currently the best (if not
the only, albeit imperfect) way the public canmonitor and be informed of the risks associatedwith administration of the COVID-19 injectables.
It is vital for the public to be aware of thisreporting system and the valuable information
therein so that informed decisions can be madeand a risk/benefit analysis done. One of the waysthat risk is assessed using findings from thisstudy is by comparing the death rate reported in
VAERS with the Infection Fatality Rate (IFR),
which is a measure of the chance of dying from4 Messenger ribonucleic acid, first discovered in 1961 at Caltech, has been called the “software of life.”

Conventional vaccine types primarily use live-attenuated whole viruses or killed viruses as a means to elicit
potent immune responses in the forms of both cellular and humoral responses and life-long immunity.
Periodically, boosts are required in order to maintain longevity of immune responses, especially in the form ofneutralizing antibodies.[42] mRNA treatment types use specific mRNA that encodes a particular protein, whichis meant to be mass-produced by host cells as a means to trigger an appropriate immune response, primarily inthe form of neutralizing antibodies, in order to provide a degree of protection upon challenge with the wild-type
coronavirus. Although studies show cellular and humoral responses upon injection, it is not known how long
immunity might last, and thus it has been suggested that many boosts will be required. It has also been detailed
that these particular vaccines do not prevent transmission, and thus the effectiveness of these vaccines is veryquestionable.[8,9,10] Perhaps even more important is that it is unknown what the impact of non-neutralizing
antibodies will be in the long term.
61

Sci, Pub Health Pol, & Law

VAERS Report on COVID-19 mRNA Biologicals – May, 2021

the SARS-CoV-2 pathogen. All infected individuals, both symptomatic and asymptomatic, areaccounted for in the IFR calculation, and data
therein is based on serology. It is important foranyone analyzing or comparing death statistics touse the IFR and not the Case Fatality Rate (CFR)— the ratio between confirmed deaths andconfirmed cases [12,13] — because the CFR isbased on potentially unreliable death andconfirmed case accounts.5 There is also a lag intime between when people are infected and when
they die, and, most importantly, it does not
capture the population with innate immunity. The
major difference in the numbers, 1.8% (CFR)
versus 0.15% (IFR), is due to a significantly
larger denominator whereby infected individuals
with an effective innate immune response
represent asymptomatic cases. The latter metrichighlights the true risk of succumbing to thevirus in the general population. It is morecompelling to use the IFR as a metric forcomparison for this and future studies.[12]side effects are transcribed along with theindividual’s age, residence by state, past medical
history, allergies and gender and many otherdetails. In addition, the vaccine lot number, placeof vaccination and manufacturer details areincluded in the report. In order to maximize theinput variables for my analysis, the three files
were merged by VAERS ID that is included as alinking variable in all three files. The merged
data set comprises data collected pertaining to allreported AEs associated with the Pfizer/
BioNtech and the Moderna COVID-19 products.
Data was sorted according to vaccine type (datareported for COVID-19) and relevant variables
were sorted including VAERS ID, AEs, age,gender, state, vaccination date, date of death,incident of death, dose series, treatment lot
number, treatment manufacturer, hospitalizations, emergency department visits and onset
date of AEs. To determine the total number ofAEs, multiple individually reported AEs were
aggregated into a single column vector. An
additional column vector called AGE_GROUPS
was created to group the individuals who madereports according to age by decade. The grouped
AE categories were created by selecting “Y” inthe case of the death, hospitalizations andemergency doctor visits while the cardiovascular,
neurological and immunological groups werecreated by selecting key words indicative of an
immunological medical issue such as ‘lymphadenopathy’, in the case of the immunological
AE group, for example.

2. Methods
1.

General methodology anddescriptive statistics

To analyse the VAERS data set, R was used (alanguage and environment for statisticalcomputing). The VAERS data set is available fordownload (https://vaers.hhs.gov/data/datasets) inthree separate comma-separated values (csv) files
representing i) general data for each report; ii)
the reported AEs or ‘symptoms’; and iii) vaccine
data including vaccine manufacturer and lot
number, as per report. The VAERS dataset is
updated approximately once a week and theuploaded set is approximately one week behind
the reports. Upon individual reporting of vaccineside effects or adverse events, a VAERS ID
number is provided to the individual to preserve
confidentiality, and a detailed description of the

There are two primary vaccine manufacturers responsible for SARS-CoV-2 vaccines
currently being administered, Pfizer/BioNTech
and Moderna. Recently, a third, the Janssen
COVID-19 Vaccine PF (produced by Johnson &Johnson), has begun to be administered. All three
are included in this analysis, except wherediscrepancies were found by comparison
between manufacturers.

5 The CFR is the fraction of reported deaths from SARS-CoV-2 to the reported confirmed cases of SARS-CoV-

2. This gives an unreliable metric in that both the numerator and denominator may not be accurate (and havebeen reported not to be).[12,13]62

Sci, Pub Health Pol, & Law

VAERS Report on COVID-19 mRNA Biologicals – May, 2021
hours of getting vaccinated did so not due to thevaccine but due to underlying conditions such asheart defects. This challenge is met by looking at
data available on potential third variable causessuch as medications taken at the time of
vaccination and existing medical conditions.
Skewing in distribution of data is tested using
Pearson’s Skewness Index, I, which is defined as
I = (mean-mode)/standard deviation. The data set
is considered to be significantly skewed if |I|≥1.

Descriptive statistics on the incidence rates
of relevant AEs were calculated as a percentageof the number of unique VAERS IDs and thefully vaccinated population in the United States.6
Also calculated are the death rates by SARSCoV-2 for each respective VAERS update dateas reported by the Our World in Data collection.
[14] It should be noted the death rate wasreported from the SARS-CoV-2 virus report
CFR, not IFR. Although a confirmed positive
serological test should be conducted, according
to the World Health Organization (WHO), theUS Department of Health and Human Services,
the CDC, the National Center for Health
Statistics, and the National Vital Statistics
System, it is acceptable to report COVID-19 on adeath certificate without this confirmation.7
2.

3. Results
1.

General information

To date, approximately 15% of the total US
population has been ‘fully vaccinated’ against
COVID-19, with 183,467,709 million doses
administered as of April 10, 2021; ~0.5% of thetotal US population have been vaccinated against
the flu, with 1,300,000 million doses administered as of March 26, 2021.8 Based on the factthat the ratio of COVID-19 to flu vaccinations at
the end of March was ~100:1, then it is not
surprising that 380 times more reports have been
made in the context of the COVID-19 injections.
99% of all AEs reported in 2021 have been in thecontext of COVID-19 reports, while only 0.3%
of all AEs reported to date have been in thecontext of the influenza vaccines. Of all vaccines
administered in 2021, 0.7% have been influenza
vaccines,9 meaning that the higher percentage ofreports made in the context of COVID-19 are due
to more frequent reporting subsequent to more
frequent administration of the COVID-19
products.

Statistical testing and causation

Statistical analysis was done using the Student’s
t-Test to determine statistically significant
differences between age groups in the context ofgrouped data, such as individuals who diedversus individuals who did not die, for example.
Causation implies that a change in one variable
necessarily leads to a change in another variable.
The three criteria for establishing causation areassociation, time ordering and non-spuriousness.
Association is shown in the incidence rate data
and using heatmaps and are corroborated using
Chi-Square Tests. Heatmaps can be found in the
Supplementary material. Time ordering ispresented in temporal relationship between
vaccination date and the following onset of AE
date or the date of death.
Non-spuriousness is more difficult to provein real-world settings since it is not truly possible
to rule out external influences as contributing
factors for the associations. For example, it ispossible that the individuals who died within 24

Figure 1.1 illustrates the total number ofadverse events reported and uploaded to the
VAERS database per year. There is an increasein the number of reports being made each year

6 Our World in Data. https://ourworldindata.org/covid-vaccinations [14]7 CDC. Guidance for Certifying Deaths Due to Coronavirus Disease 2019 (COVID–19). Vital Statistics

Reporting Guidance, Report No. 3, April 2020. https://www.cdc.gov/nchs/data/nvss/vsrg/vsrg03-508.pdf
8 CDC. Seasonal Influenza Vaccine Supply & Distribution. https://www.cdc.gov/flu/prevent/vaccine-supplydistribution.htm
9 Ibid.
63

Sci, Pub Health Pol, & Law

VAERS Report on COVID-19 mRNA Biologicals – May, 2021

Figure 1.1 Time series plot – VAERS reporting
rate normalized to US population by year

Figure 1.2 Time series plot – Absolute number
of VAERS reports for the COVID-19
products for 2021

over the past 30 years (possibly due to increasingawareness and adoption of the reporting system).
20% of all reports were COVID-19 vaccinerelated in 2020 and this was due to only 14 daysof the year since administration began on
December 17th, 2020. Figure 1.2 shows reports
for 2021 by week. The most recent updated data
files have almost surpassed the sum total reports
for the entire year in 2020 (and this includes
reports for all vaccines, not just ones related to
COVID-19). This is because reports relating to
COVID-19 vaccines in 2021 to date are in theorder of all vaccines in 2020.

AEs, 81% did so after receiving the first dose. Of
the total population of VAERS reports, 79%
were made after receiving the first dose.
1.1 Incidence rates of AE groups by
VAERS ID
As of mid-April 2021, a total of 4507 types of
AEs have been reported and 46163 VAERS IDs
have been assigned. Interestingly, of the reports,
74% came from females. This is likely due to ahigher proportion of females reporting AEs but
could stem from females succumbing to AEs
more often than males. 5%, 12% and 16% of all
AE reports involved death, hospitalization or an
emergency doctor visit, respectively, as shown in
Table 1. 18%, 12% and 35% of all AE reports
involved cardiovascular, neurological or immunological events, respectively, also shown in
Table 1.

SAEs comprise 26% of all AEs, which isalmost twice the estimate of SAEs documented inthe VAERS handbook. Of all individuals having
received the first dose who reported an SAE,
74% did so after receiving the first dose.
Similarly, of the individuals who reported mild

Table 1. Summary table showing percentages of categories and COVID-19 cases by VAERS ID10

10 The SAEs total represents all emergency room visits, hospitalizations and deaths.

64

Sci, Pub Health Pol, & Law

VAERS Report on COVID-19 mRNA Biologicals – May, 2021

Table 2. Summary table showing percentages of categories and COVID-19 cases
according to the fully vaccinated population in the US

1.2 Incidence rates of AE groups per
fully vaccinated population

In the context of the fully vaccinatedpopulation, hospitalization and ER visit reports
are at 70 and 110 per million, respectively, but asshown in Figures 2.1 and 2.2, the numbers ofthese reports are steadily increasing as the weeks
pass. 68% of all individuals who reported being
hospitalized and 77% of individuals whoreported visiting an emergency room physician
did so after the first dose.

As shown in Table 2, presuming that the deaths
are related to the injections, the incidence rate of
VAERS-reported deaths with respect to the fully
vaccinated population is quite low with 34
individuals dying per million. The fully vaccinatedpopulation comprises 20.5% of individuals asreported by Our World in Data statistical groupas of April 11, 2021.11 This is comparable to theincidence rate of SARS-CoV-2-reported deaths,
which is 730 out of every million individuals asof April 11th, 2021.5 74% of all individuals whoreported death using VAERS did so before
receiving the second dose.

With regards to AEs such as cardiovascular,
neurological and immunological events, thenumber of reports when compared to the fully
vaccinated population are currently at 120, 80
and 250 individuals per million, respectively. It
is important to remember that these reports

Figure 2.1 Time series plot — Increase in
VAERS deaths, ER visits, hospitalizations,cardiovascular, neurological andimmunological reports

Figure 2.2 Time series plot — Relative change
in deaths, ER visits, hospitalizations,cardiovascular, neurological andimmunological reports with respect to thefully vaccinated population

11 This is the death rate calculated by dividing the number of people who were reported to have died in the US

65

Sci, Pub Health Pol, & Law

VAERS Report on COVID-19 mRNA Biologicals – May, 2021

Figure 3. Distribution of age groups acrossall AEs

Figure 4.1 Distribution by VAERS ID
according to age in individuals who diedlikely under-estimate the true values by 10–100
times. Of the individuals who reported cardiovascular AEs, 81% did so after the first dose.
Likewise, 79% of the individuals who sufferedneurological AEs did so after receiving the first
dose, and 80% of the individuals who reported
suffering an immunological AE did so after
receiving the first dose as well.

scientific community. Again, it is important torecall that we are very early on in the analysis:
only four months’ worth of data has been collected
to date. For more details on statistics regarding
the most frequently reported AEs by groupaccording to dose/injection number, refer toSupplementary materials Table S1.
2.

Relative to the total number of reports, mostof the trajectories of the AEs remain stable
relative to the total number of IDs reported(Figure 2.2), with the exception of the immunological AE trajectory, which continues to rise(relative to other AE categories). Interestingly,
immunological AEs appear to dominate the AE
cases, and this warrants investigation from theDistribution of data: Age association
with vaccine-associated AEs

The distribution of all VAERS reports according
to age group is symmetric, unimodal and bellshaped across all age groups with no significant
skewing whereby |I|=0.34. (Figure 3).
The highest absolute number of events
reported are for individuals between the ages of

Figure 4.2 Distribution according to age inindividuals who were hospitalized

Figure 4.3 Distribution according to age inindividuals who visited an emergency doctor

66

Sci, Pub Health Pol, & Law

VAERS Report on COVID-19 mRNA Biologicals – May, 2021

30 and 40 years of age (which account for 18%
of all IDs), followed closely by individuals
between the ages of 40 and 60 years of age(accounting for 17% in each age group,
respectively). In general, the spread of data isnormal and symmetric with low absolute
numbers of individuals between the ages of 0 and
10 and 100 and 110.

uniform across middle-aged age groups, withmore than half of the reports (61%) made byindividuals aged 20–60 years. Neither are the
distributions for the hospitalizations nor the ER
visits skewed by age in a statistically significant
way (abs(I)=0.59 and abs(I)=0.27, respectively).
2.2 Cardiovascular, neurological andimmunological events

2.1 Deaths, hospitalizations and ER visits

A substantial proportion of individuals reported
having cardiovascular, neurological and/or
immunological events at 18%, 11% and 37%,
respectively, of the total number of reports. In
spite of the fact that individuals between the agesof 30 and 40 years comprise the largest subset ofreports overall in the context of age grouping bydecade, the highest frequency of cardiovascular
reports were made by individuals between theages of 20 and 30 years of age.

Higher absolute numbers of VAERS deaths andhospitalization reports are associated with theelderly where the cut-off for the elderly is 65
years of age, and this is not surprising (Student’s
T-Test: p<0.05; p<0.05, respectively). However,
emergency doctor visits are not associated withage (Student’s T-Test: p>0.05).
Absolute numbers of VAERS-reported
deaths grouped according to age group revealthat 84% of individuals who were the subject ofdeath reports were 70–90 years of age, as is shownin Figure 4.1. The death data is in fact leftskewed toward the elderly in a statisticallysignificant way whereby the absolute value of I is
1.15 (abs(I)=1.15). The hospitalization spread is
uniform over the age range, with 50% of reports
made by individuals between the ages of 20 and
70. 43% of hospitalization reports were made byindividuals between the ages of 70 and 90.
Emergency doctor visit reports are even more

The highest frequencies of events occur inyoung and middle-aged people in all three
categories, and this might be because they are themost vaccinated in absolute number. Neurological events were reported at the highest frequency
in individuals between the ages of 40 and 50
years old. All histograms are unimodal and bellshaped, with cardiovascular data appearing more
uniform and neurological and immunological
data being more symmetric. None of the
cardiovascular, neurological or immunologicalFigure 5.1 Distribution by VAERS ID
according to age in individuals who reported
cardiovascular adverse events

Figure 5.2 Distribution by VAERS ID
according to age in individuals who reported
neurological adverse events

67

Sci, Pub Health Pol, & Law

VAERS Report on COVID-19 mRNA Biologicals – May, 2021

Figure 5.3 Distribution by VAERS ID
according to age in individuals who reported
immunological adverse events

Figure 6. Distribution according to age inindividuals who reported anaphylactic
reactionsdata are skewed toward a specific age group in astatistically significant way (abs(I)=0.34, abs(I)=0.36, abs(I)=0.40, respectively).

statistically significant way (abs(I)=0.29). Of theindividuals who reported an anaphylactic reaction,
76% did so after receiving the first dose.

2.3 Anaphylactic reactions

2.4 Spontaneous abortions

Anaphylactic reactions are reported in the VAERS
database at a rate of 1%. Anaphylaxis was reported
in individuals primarily between the ages of 30
and 60 years of age, yet distribution of the data
symmetric, unimodal and bell-shaped over theage range, as shown in Figure 6. This particular
AE is interesting to examine from a causation
point of view since most reactions of this nature
are known to be caused by specific triggers. It has
been reported that one such trigger, poly-ethylene
glycol (PEG), is an ingredient in the Modernaand Pfizer/BioNTech products.[15] It is also
documented that polysorbate is an ingredient in
the Janssen COVID-19 Vaccine PF product, andindividuals are advised against using it if aknown allergy exists for polysorbate. In manycases, individuals are unaware of the potential foran acute allergic response. In the following section,
it will become clearer from time-series plots andheatmaps that causation is not only likely but
probable.

Spontaneous abortions are not technically
included as deaths as part of the VAERS data,but miscarriages involve foetal death. Since thenumber of these reports is increasing on averageby six per week, it is included in this analysis asa stand-alone AE and classified as a severe
adverse event. Spontaneous abortions werereported in females between the ages of 20 and
45 and were more frequent in women in theirearly 30s. This is likely due to more women in
their early 30s being pregnant more frequently.
Figure 7. Distribution by age in individuals
who reported spontaneous abortions

Anaphylactic events are reported withhighest frequency in individuals between the agesof 40 and 50 years old. The distribution of data is
not skewed toward a specific age group in a68Sci, Pub Health Pol, & Law

VAERS Report on COVID-19 mRNA Biologicals – May, 2021
Figure 8.1 Time series plot — Percentage ofreported deaths by time elapsed between theinjection date and the reported adverse event

Table 3. Percentages of individuals reportingAEs following 24- and 48-hour periods
AE within 24 hrs AE within 48 hrs(% of cases)(% of cases)
Death
Hospital
ER

13
15
18

44
47
47

The distribution of data is not skewed toward a
specific age in a statistically significant way(abs(I)=0.1). Of the women who reported having
a spontaneous abortion, 65% did so after
receiving the first dose. In the following section,
the likelihood of causation is investigated since it
is absolutely necessary to elucidate theconditions that induced miscarriage in these
women, since plans for large-scale roll-out ofthese products into pregnant women are looming
or currently active.
3.

Figures 8.1–3 shows the number of days
following injection as a percentage of the reported
AEs with regards to deaths, hospitalizations andemergency doctor visits. The percentages ofreported deaths, hospitalizations and emergency
doctor visits are highest in the first two days
post-injection.

Evidence to support causation

A causal effect means that a change in one variableleads to change in another variable. In the context
of all the AEs, 70% of all individuals had onsetof symptoms within 48 hours following first or
second doses. Table 3 shows the percentages ofindividuals succumbing to particular AEs following a 24-hour or 48-hour period.

If deaths, for example, following COVID-19
injections are not causally linked, then thereported percentages of deaths should be equallydistributed across days following injection: there
should not be an excess of reports on days 0, 1
and 2, yet there are. Chi-square tests confirm
association for each AE group with p-values lessthan 0.001 in each case. If risk is not accentuatedFigure 8.2 Time series plot — Percentage ofreported hospitalizations by time elapsed
between injection date and adverse event

Figure 8.3 Time series plot — Percentage ofreported emergency doctor visits by time
elapsed between injection and adverse event69Sci, Pub Health Pol, & Law

VAERS Report on COVID-19 mRNA Biologicals – May, 2021

Figure 9.1 Time series plot — Percentage ofreported cardiovascular AEs by time elapsed
between injection date and adverse event

Figure 9.2 Time series plot — Percentage ofreported neurological AEs by time elapsed
between injection date and adverse event

by some immediate factor temporally, then thatrisk should necessarily plateau or diminish eachday (see Supplementary Figures 1.1–1.3). This
logic applies to each of the grouped AEs andeach follows the same pattern: the percentages of
Day 0 and 1 (time periods representing 0–24 hours
and 24–48 hours) are much higher than thepercentages of other time periods post-injection.

excess of reports on days 0, 1 and 2. Chi-square
tests confirm association for each AE group withp-values less than 0.001 in each case. Table 4shows the percentages of individuals succumbing
to particular AEs following a 24-hour or 48-hour
period.
There is a higher percentage (7%) ofindividuals who reported immunological eventson the seventh day following injection, as shownin Figure 9.3. From an immunological point ofview, this could be worth investigating in further
studies.

This same reasoning applies to the grouped
AEs representing cardiovascular, neurologicaland immunological events as shown in Figures
9.1–3. The percentages of cardiovascular, neurological and immunological events are highest in
the first two days post-injection. Again, if
causation was absent, there should not be an

Figures 10.1 and 10.2 show the same trend
toward the highest percentages of anaphylactic
reactions and spontaneous abortions occurring in
the first two days post-injection. A staggering
87% of all anaphylactic reactions were reported
within 48 hours and 76% were reported within
24 hours. This is not surprising, considering thenature of this stand-alone AE. One would expect

Figure 9.3 Time series plot — Percentage ofreported immunological AEs by time elapsed
between injection date and adverse event

Table 4. Percentages of individuals
experiencing AEs within 24- and 48-hour
periods
AE within 24 hrs AE within 48 hrs(% of cases)(% of cases)
Cardiovascular
Neurological
Immunological
70

13
15
18

44
47
47

Sci, Pub Health Pol, & Law

VAERS Report on COVID-19 mRNA Biologicals – May, 2021

Figure 10.1 Time series plot — Percentage ofreported anaphylaxis with respect to time
elapsed between date of injection and AE

Figure 10.2 Time series plot — Percentage ofreported spontaneous abortions by time
elapsed between date of injection and AE

an anaphylactic reaction to occur quite
immediately. More than half (61%) of all
spontaneous abortions were reported within 48
hours of injection, and 42% within 24 hours. See
Supplementary Figures S1.1–S3.2 for corroborative heatmaps.

in ~6% of the individuals, and on the facet ofprior conditions which may have led to death,
only 8.5% of the individuals had some heartrelated incident reported in their prior history.
This was the highest percentage of conditions
reported in the medical histories. It should be
acknowledged that the VAERS-reported medical
history is bound to be incomplete, and therefore it
is possible that the AEs in question could be due
to conditions not reported in VAERS data. Basedon the data available, the three conditions of
causation are satisfied, in general, but I leave it
up to the reader to extrapolate beyond the data.

These descriptive statistics give merit toassociation and time ordering post-injection in
the contexts of these categorized AEs. In order torule out spuriousness, the potential contributionof additional variables, including pre-existing
conditions and medications, that could havecontributed to death were examined. Of the
medications, the most frequently reported occurred

4.

Figure 11. Time series plot — Increase inabsolute number of COVID-19 confirmed
cases from VAERS data

Confirmed COVID-19 cases postvaccination

A total of 1267 COVID-19 cases have beenreported to date with the Pfizer/BioNTech
product representing a 3% rate and the Moderna
product representing a 0.5% rate. Since the Janssen
product first appeared in the VAERS system asof two weeks ago, a low 0.007% rate is not
surprising. The latter, included in Table 2, is dataon the change in COVID-19 confirmed cases,
which relative to the fully vaccinated population
is decreasing, but increasing absolutely. Figure
11 illustrates this increase over time, whichappears to be a linear trajectory.
Distribution of COVID-19 cases invaccinated individuals across age groups is71

Sci, Pub Health Pol, & Law

VAERS Report on COVID-19 mRNA Biologicals – May, 2021

Figure 12. Distribution of COVID-19
confirmed cases from VAERS data by age

Figure 13. Distribution of COVID-19 cases
according to vaccine manufacturer

individuals in every million die from to the virus.
Of the SAEs in the data reported so far, while
taking the reported numbers at face value, themost undesirable reported is death. According tocurrent VAERS data, 34 individuals per million
will succumb to death. The rates are slightly
higher at 120, 80 and 250 per million pertaining
to specific AEs involving cardiovascular, neurological or immunological events. The risk overall,according to analysis of this data set, appears tobe quite low. However, again, this data is very
early and, in the context of a rushed, non-FDAapproved, ongoing experimental roll-out,
conclusions about long-term outcomes cannot bemade yet. The VAERS data is very dynamic andnew patterns may emerge at any time, dependingon new reports.

uniform across the age groups between 30 and 90
years, as shown in Figure 12. No skewing was
found relating a specific age group to COVID-19
case that was statistically significant. The
skewness should be compared versus thevaccinated/reporting population and not within
the data subset itself, but this is for a future
study.
When the COVID-19 data is examined bymanufacturer, it stands out that 81% of all
confirmed COVID-19 cases are associated with
the Pfizer/BioNTech product. Without knowing
the distribution proportions of the manufacturers
in the population base, it is not possible to makeclaims about this sample with regards to any
potential higher probability of getting COVID-19
in the context of the Pfizer/BioNTech product. If
this data can be acquired, this question can be
answered. This is reserved for a future study.
Figure 13 shows the distribution of confirmed
COVID-19 cases in VAERS reports acrossvaccine manufacturer.

The infection fatality rate (IFR), which isthe number of individuals who died fromCOVID-19 among all infected individuals (bothsymptomatic and asymptomatic) is estimated tobe 0.15% or 1500 individuals per million.[12,13]
Thus, if compared to the death rate reported inthe VAERS database in the context of the
COVID-19 injections, which is 0.0034% or 34
individuals per million, the chance of dying from
SARS-CoV-2 is greater than from the injections,based on data collected from the past fourmonths. It is vital to remember here that theactual number of adverse events ongoing are
likely being under-reported, and there are likely
to be thousands more backlogged due to underrecording. If the estimated death rate is two

4. Discussion
Safety and efficacy are the two requirements ofany true vaccine. Based on this study, the risk of
suffering an SAE following injection is minimal,
with an average of 200 individuals succumbing
to an SAE per million. By comparison, 1,500
72

Sci, Pub Health Pol, & Law

VAERS Report on COVID-19 mRNA Biologicals – May, 2021

orders of magnitude greater in reality, which itvery well could be, this puts the death rate closer
to 3,400 individuals per million, which is higher
than the IFR estimate. Despite the fact that
20.5% of the US population is fully vaccinated,the death count is still rising at a constant rateaccording to Our World in Data statistics. If one
looks to Israel, the country with the most fully
vaccinated individuals at 57.26%, it is clear tosee that the death count remains on a steadyupward trajectory (Supplementary Figures S4.1
and S4.2).[14,16]

patients [26,27,28,29,30,31,32, 33,34,35,36], it isalso unclear why these drugs are not being more
extensively promoted as effective tools in thefight against this virus. One looming possibility
is that EUA is not permissible if FDA-recognized,
effective treatments exist.

5. Conclusion
This work summarizes VAERS data to date
(April 9th, 2021) and serves as information forthe public and a reminder of the relevance of any
adverse events, including deaths, that likely
occurred as a direct result of vaccine administration. Based on analysis of the VAERS numbers,
it may appear that AEs are not currently
imposing a significant burden on the fully
vaccinated population; however, the weekly
releases of VAERS data do not include all of thereports made to date — they are all the reports
the CDC has processed to date — and thebacklog is likely to be staggering. Thus, due toboth the problems of under-reporting and the lagin report processing, this analysis reveals astrong signal from the VAERS data that the riskof suffering an SAE following injection issignificant and that the overall risk signal is high.

In a recent CDC report titled ‘Local
Reactions, Systemic Reactions, Adverse Events,
and Serious Adverse Events: Pfizer-BioNTech
COVID-19 Vaccine’,[18,19] only the severity ofthe most frequently reported AEs in the VAERS
database are reported in tabular form and not the
SAEs themselves. They report that occurrence ofsevere adverse events involving system organclasses and specific preferred terms werebalanced between vaccine and placebo groups
and presented at a mere 0.5%. Although SAEs
(grade ≥3, defined as interfering with daily
activity) occurred more commonly in vaccine
recipients than in placebo recipients, their claim
is that no specific safety concerns were identified
with regards to SAEs.[18,19] Supplementary
Table S1 provides details of the frequencies ofSAEs divided by deaths, hospitalizations andemergency doctor visits. It provides a more
complete picture of the SAE occurrences andfrequencies in specific contexts.

Analysis suggests that the vaccines arelikely the cause of reported deaths, spontaneousabortions and anaphylactic reactions in addition
to cardiovascular, neurological and immunological AEs. Based on the precautionary
principle, since there is currently no precedentfor predictability with regards to long-term
effects from mRNA injections, extreme careshould be taken when making a decision toparticipate in this experiment. mRNA platforms
are new to humans with regard to mass injection
programs in the context of viruses. There iscurrently no way to predict potential detrimental
outcomes with regards to SAE occurrences in thelong-term. Also, with regards to short-term
analysis, this data is limited based on reportingthat likely significantly underestimates actual
events.

Effective antiviral responses against the
SARS-CoV-2 virus in the form of both cellularand humoral immune responses have beenreported in peer-reviewed studies.[20,21,22,23,24,
25] Because of the combination of a low IFR
indicating effective and robust immune
responses, it remains unclear why multiple
experimental mRNA vaccines have been fasttracked through conventional testing protocols
and are also being fast-tracked throughproduction and administra-tion into the public.
With repurposed drugs like Chloroquine andIvermectin showing extremely positive results in73

Sci, Pub Health Pol, & Law

VAERS Report on COVID-19 mRNA Biologicals – May, 2021

It cannot be emphasized enough that this isvery early data and that, based on the dynamic
nature of the data, these conclusions may not be
the same in a month’s time. The efficacy of theseproducts needs to be assessed by immunologicalassays, and long-term studies are required, whilesafety needs to be evaluated by rigorous clinical,
laboratory and imaging assessments of severereported adverse events. Autopsies should bedone in cases of deaths temporally associatedwith COVID-19 injectables.

6. References
1.

2.

3.

Overall, it is vital not to be hasty and to
make a proper risk assessment by being informed
prior to making a decision as to whether or not toparticipate in experimental trials.
Treatments against SARS-CoV-2 and subsequent COVID-19 symptom formation are meant
to minimize harm from the latter. It appears fromthis analysis that these treatments are, in fact,
doing more harm than good when considering thepoints made herein, especially in the context ofspecific risk groups which are the very people weare claiming to want to protect.

4.

Future work may include an investigation
into potential correlations between SAE
occurrences and frequencies and vaccine lot
number, and of course updates should be made inaccordance with the VAERS weekly update. In
addition, investigation and focus on immunological issues MUST be a priority in futurestudies with regards to adverse events reports
related to COVID-19 biologicals.

5.

6.

Funding and Conflict of Interest Information
This article received no specific funding.
No conflicts of interest are declared.

7.

Editor-in-Chief and Reviewing Editor:
James Lyons-Weiler, PhD

8.
74

US Department of Health & Human Services.
VAERS Data Use Guide. November 2020.
https://vaers.hhs.gov/docs/VAERSDataUseGuid
e_November2020.pdf
Iannelli V. Underreporting of Side Effects to
VAERS. September 17, 2017.
https://vaxopedia.org/2017/08/26/underreportin
g-of-side-effects-to-vaers
Demeure CE, Derbise A, Guillas C, Gerke C,
Cauchemez S, Carniel E, Pizarro-Cerdá J.
Humoral and cellular immune correlates ofprotection against bubonic plague by a live
Yersinia pseudotuberculosis vaccine. Vaccine.
2019 Jan 3;37(1):123–129. doi:
10.1016/j.vaccine.2018.11.022. Epub 2018 Nov
19. PMID: 30467064.
Walsh EE, Frenck RW Jr, Falsey AR, Kitchin
N, Absalon J, Gurtman A, Lockhart S, Neuzil
K, Mulligan MJ, Bailey R, Swanson KA, Li P,
Koury K, Kalina W, Cooper D, Fontes-Garfias
C, Shi PY, Türeci Ö, Tompkins KR, Lyke KE,
Raabe V, Dormitzer PR, Jansen KU, Şahin U,
Gruber WC. Safety and Immunogenicity of
Two RNA-Based Covid-19 Vaccine
Candidates. N Engl J Med. 2020 Dec
17;383(25):2439-2450. doi:
10.1056/NEJMoa2027906. Epub 2020 Oct 14.
PMID: 33053279; PMCID: PMC7583697.
Polack FP, et al. C4591001 Clinical Trial
Group. Safety and Efficacy of the BNT162b2
mRNA Covid-19 Vaccine. N Engl J Med. 2020
Dec 31;383(27):2603–2615. doi:
10.1056/NEJMoa2034577. Epub 2020 Dec 10.
PMID: 33301246; PMCID: PMC7745181.
McVey DS, Galvin JE, Olson SC. A review ofthe effectiveness of vaccine potency control
testing. Int J Parasitol. 2003 May;33(5-6):50716. doi: 10.1016/s0020-7519(03)00067-5.
PMID: 12782051
WHO. COVID-19 Global literature on
coronavirus disease. Last accessed: 5/16/2021.
http://search.bvsalud.org/global-literature-onnovel-coronavirus-2019-ncov/
CDC. Interim Public HealthSci, Pub Health Pol, & Law

9.

10.

11.

12.

13.

14.
15.

16.

VAERS Report on COVID-19 mRNA Biologicals – May, 2021

Recommendations for Fully VaccinatedPeople. May 13, 2021.
https://www.cdc.gov/coronavirus/2019ncov/vaccines/fully-vaccinated-guidance.html
Medicines.org.uk. 2021. Package leaflet:
Information for the recipient: COVID-19
mRNA Vaccine BNT162b2 concentrate forsolution for injection.
https://www.medicines.org.uk/emc/files/pil.124
35.pdf
FDA. Fact Sheet for Healthcare Providers
Administering Vaccine (Vaccination
Providers)Emergency Use Authorization (EUA) of the
Pfizer-BioNTech COVID-19 Vaccine toPrevent Coronavirus Disease 2019 (COVID19). 2021. Last accessed: 5/16/2021 (Revised
10 May 2021).
https://www.fda.gov/media/144413/download
Dagan N, Barda N, Kepten E, Miron O, Perchik
S, Katz MA, Hernan MA, Lipsitch M, Reis B,
and Balicer RD. BNT162b2 mRNA Covid-19
Vaccine in a Nationwide Mass Vaccination
Setting. New England Journal of Medicine.
February 24, 2021. DOI:
10.1056/NEJMoa2101765
Ioannidis JP. Reconciling estimates of global
spread and infection fatality rates of
COVID‐19: an overview of systematic
evaluations. Eur J Clin Invest. 2021. Accepted
Author Manuscript e13554.
https://doi.org/10.1111/eci.13554
Noh J, Danuser G. Estimation of the fractionof COVID-19 infected people in U.S. states
and countries worldwide. PLoS ONE 2021
16(2): e0246772.
https://doi.org/10.1371/journal.pone.0246772
Our World in Data. https://ourworldindata.org
CDC. Information about COVID-19
Vaccines for People with Allergies. Mar. 25,
2021. https://www.cdc.gov/coronavirus/2019ncov/vaccines/recommendations/specificgroups/allergies.html
Carmoz, D. 2021. Israeli Ministry of Health’s
COVID-19 data. Last Accessed, 5/16/2022.
https://github.com/dancarmoz/israel_moh_covi
d_dashboard_data

17.

18.

19.

20.

21.

22.

23.

24.

75

Statista. Coronavirus (COVID-19) death rate
in countries with confirmed deaths and over
1,000 reported cases as of May 12, 2021, bycountry.
https://www.statista.com/statistics/1105914/
coronavirus-death-rates-worldwide/
CDC. Local Reactions, Systemic Reactions,
Adverse Events, and Serious Adverse Events:
Pfizer-BioNTech COVID-19 Vaccine.
https://www.cdc.gov/vaccines/covid-19/infoby-product/pfizer/reactogenicity.html
CDC. The Advisory Committee on
Immunization Practices’ Interim
Recommendation for Use of Pfizer-BioNTech
COVID-19 Vaccine — United States,
December 2020.
https://www.cdc.gov/mmwr/volumes/69/wr/mm
6950e2.htm?s_cid=mm6950e2_w
Toor SM, Saleh R, Sasidharan Nair V, Taha
RZ, Elkord E. T-cell responses and therapies
against SARS-CoV-2 infection. Immunology.
2021 Jan;162(1):30–43. doi:
10.1111/imm.13262. Epub 2020 Oct 27. PMID:
32935333; PMCID: PMC7730020.
Robbiani DF, et al. Convergent antibody
responses to SARS-CoV-2 in convalescentindividuals. Nature. 2020 Aug;584(7821):437–
442. doi: 10.1038/s41586-020-2456-9. Epub2020 Jun 18. PMID: 32555388; PMCID:
PMC7442695.
Sun B, et al. Kinetics of SARS-CoV-2 specific
IgM and IgG responses in COVID-19
patients. Emerg Microbes Infect. 2020
Dec;9(1):940–948. doi:
10.1080/22221751.2020.1762515. PMID:
32357808; PMCID: PMC7273175.
Le Bert N, et al. SARS-CoV-2-specific T cell
immunity in cases of COVID-19 and SARS,
and uninfected controls. Nature. 2020
Aug;584(7821):457–462. doi: 10.1038/s41586020-2550-z. Epub 2020 Jul 15. PMID:
32668444.
Mateus J, et al. Selective and cross-reactive
SARS-CoV-2 T cell epitopes in unexposed
humans. Science. 2020 Oct 2;370(6512):89–94.
doi: 10.1126/science.abd3871. Epub 2020 Aug
4. PMID: 32753554; PMCID: PMC7574914.

Sci, Pub Health Pol, & Law
25.

26.

27.

28.

29.

30.

31.

VAERS Report on COVID-19 mRNA Biologicals – May, 2021

Lipsitch M, Grad YH, Sette A, Crotty S. Crossreactive memory T cells and herd immunity
to SARS-CoV-2. Nat Rev Immunol. 2020
Nov;20(11):709–713. doi: 10.1038/s41577-02000460-4. Epub 2020 Oct 6. PMID: 33024281;
PMCID: PMC7537578.
Colson P, Rolain JM, Lagier JC, Brouqui P,
Raoult D. Chloroquine andhydroxychloroquine as available weapons tofight COVID-19. Int J Antimicrob Agents.
2020 Apr;55(4):105932. doi:
10.1016/j.ijantimicag.2020.105932. Epub 2020
Mar 4. PMID: 32145363; PMCID:
PMC7135139.
Meo SA, Klonoff DC, Akram J. Efficacy ofchloroquine and hydroxychloroquine in thetreatment of COVID-19. Eur Rev Med
Pharmacol Sci. 2020 Apr;24(8):4539-4547. doi:
10.26355/eurrev_202004_21038. PMID:
32373993.
Ibáñez S, Martínez O, Valenzuela F, Silva F,
Valenzuela O. Hydroxychloroquine andchloroquine in COVID-19: should they beused as standard therapy? Clin Rheumatol.
2020 Aug;39(8):2461–2465. doi:
10.1007/s10067-020-05202-4. Epub 2020 Jun
3. PMID: 32495226; PMCID: PMC7267470.
N, Esposito S. Chloroquine orhydroxychloroquine for prophylaxis of
COVID-19. Lancet Infect Dis. 2020
Oct;20(10):1118. doi: 10.1016/S14733099(20)30296-6. Epub 2020 Apr 17. PMID:
32311322; PMCID: PMC7164862.
Ferner RE, Aronson JK. Chloroquine andhydroxychloroquine in Covid-19. BMJ. 2020
Apr 8;369:m1432. doi: 10.1136/bmj.m1432.
PMID: 32269046.; Hernandez AV, Roman YM,
Pasupuleti V, Barboza JJ, White CM.
Hydroxychloroquine or Chloroquine forTreatment or Prophylaxis of COVID-19: A
Living Systematic Review. Ann Intern Med.
2020 Aug 18;173(4):287–296. doi:
10.7326/M20-2496. Epub 2020 May 27. PMID:
32459529.;
Shah S, Das S, Jain A, Misra DP, Negi VS. A
systematic review of the prophylactic role ofchloroquine and hydroxychloroquine in

32.

33.

34.

35.

36.

37.

38.
39.

40.
76

coronavirus disease-19 (COVID-19). Int J
Rheum Dis. 2020 May;23(5):613–619. doi:
10.1111/1756-185X.13842. Epub 2020 Apr 27.
PMID: 32281213; PMCID: PMC7262257.
Rizzo E. Ivermectin, antiviral properties and
COVID-19: a possible new mechanism ofaction. Naunyn Schmiedebergs Arch
Pharmacol. 2020 Jul;393(7):1153–1156. doi:
10.1007/s00210-020-01902-5. Epub 2020 May
27. PMID: 32462282; PMCID: PMC7251046.
Heidary F, Gharebaghi R. Ivermectin: asystematic review from antiviral effects to
COVID-19 complementary regimen. J
Antibiot (Tokyo). 2020 Sep;73(9):593–602. doi:
10.1038/s41429-020-0336-z. Epub 2020 Jun
12. PMID: 32533071; PMCID: PMC7290143.
Sharun K, Dhama K, Patel SK, Pathak M,
Tiwari R, Singh BR, Sah R, Bonilla-Aldana
DK, Rodriguez-Morales AJ, Leblebicioglu H.
Ivermectin, a new candidate therapeutic
against SARS-CoV-2/COVID-19. Ann Clin
Microbiol Antimicrob. 2020 May 30;19(1):23.
doi: 10.1186/s12941-020-00368-w. PMID:
32473642; PMCID: PMC7261036.
Shih RD, Johnson HM, Maki DG, Hennekens
CH. Hydroxychloroquine for coronavirus:
The urgent need for a moratorium onprescriptions. Am J Med. 2020
Sep;133(9):1007–1008. doi:
10.1016/j.amjmed.2020.05.005. Epub 2020 Jun
2. PMID: 32502485; PMCID: PMC7265864.
Lam S, Lombardi A, Ouanounou A. COVID19: A review of the proposed
pharmacological treatments. Eur J
Pharmacol. 2020 Nov 5;886:173451. doi:
10.1016/j.ejphar.2020.173451. Epub 2020 Aug
6. PMID: 32768505; PMCID: PMC7406477.
Drugs. Pfizer-BioNTech COVID-19 Vaccine
FDA Approval Status.
https://www.drugs.com/history/pfizer-biontechcovid-19-vaccine.html
Drugs. mRNA-1273 FDA Approval Status.
https://www.drugs.com/history/mrna-1273.html
Drugs. Janssen Pharmaceuticals, Inc..
https://www.drugs.com/manufacturer/janssenpharmaceuticals-inc-74.html
National Institute on Aging. NIA Adverse

Sci, Pub Health Pol, & Law

41.

42.

43.

44.

45.

46.

47.

48.
49.

VAERS Report on COVID-19 mRNA Biologicals – May, 2021

Event and Serious Adverse Event Guidelines.
https://www.nia.nih.gov/sites/default/files/2018-09/nia-ae-and-sae-guidelines-2018.pdf
FDA. Code of Federal Regulations — Title
21 — Food and Drugs.
https://www.accessdata.fda.gov/scripts/cdrh/cfd
ocs/cfcfr/cfrsearch.cfm?frexternal%20icon
Poorolajal J, Hooshmand E. Booster dose
vaccination for preventing hepatitis B.
Cochrane Database Syst Rev. 2016 Jun
7;2016(6):CD008256. doi:
10.1002/14651858.CD008256.pub3. PMID:
27271960; PMCID: PMC7154826.
CDC. Guidance for Certifying Deaths Due toCoronavirus Disease 2019 (COVID–19). Vital
Statistics Reporting Guidance. Report No. 3,
April 2020.
https://www.cdc.gov/nchs/data/nvss/vsrg/vsrg0
3-508.pdf
CDC. Seasonal Influenza Vaccine Supply &Distribution.
https://www.cdc.gov/flu/prevent/vaccinesupply-distribution.htm
Poon, L.L.M., Peiris, M. Emergence of a novel
human coronavirus threatening humanhealth. Nat Med 26, 317–319 (2020).
https://doi.org/10.1038/s41591-020-0796-5
Galloway SE, Paul P, MacCannell DR, et al.
Emergence of SARS-CoV-2 B.1.1.7 Lineage— United States, December 29, 2020–January
12, 2021. Morb Mortal Wkly Rep
2021;70:95–99.
Harcourt J, Tamin A, Lu X, et al. Severe AcuteRespiratory Syndrome Coronavirus 2 fromPatient with Coronavirus Disease, UnitedStates. Emerging Infectious Diseases.
2020;26(6):1266–1273.
doi:10.3201/eid2606.200516.
Pfizer, Inc. https://www.pfizer.com
IPAK Report 2021–1. 2021. Post-vaccination
Death Causality Likely Given Temporal
Distribution of Deaths Following COVID19
Vaccinations. Interim results.
http://ipaknowledge.org/resources/VAERS%20
deaths%20to%203%2010%202021%20update%203.pptx

50.

51.

52.

53.

54.

55.

77

Tinari S. The EMA Covid-19 data leak, andwhat it tells us about mRNA instability. BMJ
2021; 372 :n627 doi:10.1136/bmj.n627
UK Government Publishing Service. SPI-M-O:
Summary of further modelling ofeasing
restrictions–Roadmap Step 2. March 31,
2021.
https://assets.publishing.service.gov.uk/govern
ment/uploads/system/uploads/attachment_data/f
ile/975909/S1182_SPI-M-O_Summary_of_modelling_of_easing_roadmap_step_2_restricti
ons.pdf
Corbett, K.S., Edwards, D.K., Leist, S.R. et al.
SARS-CoV-2 mRNA vaccine design enabledby prototype pathogen preparedness. Nature
586, 567–571 (2020).
https://doi.org/10.1038/s41586-020-2622-0.
Jaafar R, Aherfi S, Wurtz N, Grimaldier C, Van
Hoang T, Colson P, Raoult D, La Scola B.
Correlation Between 3790 Quantitative
Polymerase Chain Reaction–Positives
Samples and Positive Cell Cultures,
Including 1941 Severe Acute Respiratory
Syndrome Coronavirus 2 Isolates. Clinical
Infectious Diseases. 2020; ciaa1491.
https://doi.org/10.1093/cid/ciaa1491
Braunstein GD, Schwartz L, Hymel P, Fielding
J. False Positive Results With SARS-CoV-2
RT-PCR Tests and How to Evaluate a RTPCR-Positive Test for the Possibility of a
False Positive Result. Journal of Occupational& Environmental Medicine. 2021 Mar
1;63(3):e159-e162.
doi:10.1097/JOM.0000000000002138.
Alroy KA, et al. Population-Based Estimatesof Coronavirus Disease 2019 (COVID19)–like Illness, COVID-19 Illness, and Rates
of Case Ascertainment, Hospitalizations, andDeaths—Noninstitutionalized New York City
Residents, March–April 2020. Clinical
Infectious Diseases. 2021; ciab038.
https://doi.org/10.1093/cid/ciab038

Sci, Pub Health Pol, & Law

VAERS Report on COVID-19 mRNA Biologicals – May, 2021
Any value on the diagonal has an R-value of 1,
meaning a perfect correlation.

7. Supplementary Figures
These findings are illustrated using heatmaps.
Heatmaps cross-classify the distributions of two
continuous variables (i.e. vaccination date andonset of symptoms or date of death) by reportinga frequency count, n, against a condition. The
condition imposed is the count of n with n=0, 1,… , m where m is the number of days with theassigned number ‘n’. They are incredibly
informative in that many data points can becross-correlated and ‘mapped’ at once.

Figure S1.3 Intersection of vaccination dates
and date of emergency doctor visit

For this study, each tile is shaded according
to the number of intersections, with blue representing the lowest number of event inter-sections
and red representing the highest.
Figure S1.1 Intersection of vaccination dates
and date of death with respect to ID countFigure S2.1 Intersection of dates ofvaccination and cardiovascular AE withrespect to ID count for symptom group

Figure S1.2 Intersection of dates ofvaccination and hospitalization

Figure S2.2 Intersection of dates ofvaccination and neurological AE with respect
to ID count for symptom group78

Sci, Pub Health Pol, & Law

VAERS Report on COVID-19 mRNA Biologicals – May, 2021

Figure S2.3 Intersection of dates ofvaccination and immunological AE withrespect to ID count for symptom group

Figure S4.1 Time series plot — Fully
vaccinated population in Israel

Figure S4.2 Time series plot — nCoV-2019

Figure S3.1 Intersection of dates ofvaccination and anaphylaxis with respect to
ID count for the symptom group

Chi-Square Test Calculations in R
Death
Chi-squared test for given probabilities
data:
MERGED_SYM_DAT_VAX_23_04_2021_830
0kb_VD_DD$OBSERVED
X-squared = 3909.5, df = 50, p-value < 2.2e-16

Figure S3.2 Intersection of dates ofvaccination and spontaneous abortion withrespect to ID count for the symptom group

Hospitalizations
Chi-squared test for given probabilities
data:
MERGED_SYM_DAT_VAX_23_04_2021_830
0kb_H_VD_OD$OBSERVED
X-squared = 31658, df = 50, p-value < 2.2e-16

79

Sci, Pub Health Pol, & Law

VAERS Report on COVID-19 mRNA Biologicals – May, 2021

Table S1. Most frequently reported AEs by group according to dose/injection number
AE group

Dose 1(N(%))

Dose 2(N (%))

Death
HospitalER
Cardiovascular
Neurological
Immunological
ALL AEs

602 (48)
178 (7)225 (5.5)1458 (28)
978 (30)
2878 (27)2273 (9.2)

206 (48)
95 (8)
74 (6)
259 (21)252 (37)
1187 (44)1016 (16)Emergency doctor visits
Chi-squared test for given probabilities
data:
MERGED_SYM_DAT_VAX_23_04_2021_830
0kb_ER_VD_OD$OBSERVED
X-squared = 144097, df = 50, p-value < 2.2e-16

Total AE Dose 1(N (%))
1252 (74)2525 (68)4069 (77)5,289 (81)3268 (82)10640 (80)24544 (79)

Total AE Dose 2(N (%))
430 (26)
1193 (32)1238 (23)1214 (19)697 (18)2705 (20)6495 (21)Anaphylactic AEs
Chi-squared test for given probabilities
data:
MERGED_SYM_DAT_VAX_23_04_2021_830
0kb_ANAP_VD_OD$OBSERVED
X-squared = 3497.3, df = 13, p-value < 2.2e-16

Cardiovascular AEs
Chi-squared test for given probabilities
data:
MERGED_SYM_DAT_VAX_23_04_2021_830
0kb_CV_VD_OD$OBSERVED
X-squared = 204191, df = 47, p-value < 2.2e-16
Neurological AEs
Chi-squared test for given probabilities
data:
MERGED_SYM_DAT_VAX_23_04_2021_830
0kb_NEURO_VD_OD$OBSERVED
X-squared = 93039, df = 42, p-value < 2.2e-16
Immunological AEs
Chi-squared test for given probabilities
data:
MERGED_SYM_DAT_VAX_23_04_2021_830
0kb_IMMUNO_VD_OD$OBSERVED
X-squared = 275292, df = 44, p-value < 2.2e-16
Spontaneous Abortions
Chi-squared test for given probabilities
data:
MERGED_SYM_DAT_VAX_23_04_2021_830
0kb_SA_VD_OD$OBSERVED
X-squared = 90.783, df = 24, p-value = 1.069e09

80