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COVID-19 Vaccine Safety Signals in VAERS

Bayesian Disproportionality Analysis Across Nine Vaccine Products

Author

Global Patient Safety

Published

May 5, 2026

Show code 
library(arrow)
library(dplyr)
library(tidyr)
library(ggplot2)
library(forcats)
library(gt)
library(scales)
library(stringr)

# Aggregated signals (no quarter column) — used for most analyses
SIGNALS_PATH    <- "/srv/shiny-server/gps-patient/data/signals_vaers.parquet"
# Pre-computed first-emergence table (drug, event, first_quarter) — ~85KB
FIRST_SEEN_PATH <- "/srv/shiny-server/gps-patient/data/covid_first_seen.parquet"

label_vaccine <- function(drug) {
  case_when(
    grepl("PFIZER.*BIVALENT|BIVALENT.*PFIZER", drug, ignore.case = TRUE) ~ "Pfizer Bivalent",
    grepl("MODERNA.*BIVALENT|BIVALENT.*MODERNA", drug, ignore.case = TRUE) ~ "Moderna Bivalent",
    grepl("PFIZER|BIONTECH|COMIRNATY",           drug, ignore.case = TRUE) ~ "Pfizer-BioNTech",
    grepl("MODERNA|SPIKEVAX|MNEXSPIKE",           drug, ignore.case = TRUE) ~ "Moderna",
    grepl("JANSSEN|JOHNSON",                      drug, ignore.case = TRUE) ~ "Janssen (J&J)",
    grepl("NOVAVAX",                              drug, ignore.case = TRUE) ~ "Novavax",
    TRUE ~ "Unknown"
  )
}

vaers_raw <- open_dataset(SIGNALS_PATH) |> collect()

covid <- vaers_raw |>
  filter(grepl("COVID|SARS|BNT|MRNA", drug, ignore.case = TRUE)) |>
  mutate(
    vaccine  = label_vaccine(drug),
    platform = case_when(
      vaccine %in% c("Pfizer-BioNTech", "Moderna",
                     "Pfizer Bivalent", "Moderna Bivalent") ~ "mRNA",
      vaccine == "Janssen (J&J)"                            ~ "Viral vector",
      vaccine == "Novavax"                                  ~ "Protein subunit",
      TRUE ~ "Unknown"
    )
  )

# First-emergence: earliest quarter each (drug, event) pair crossed ≥2 methods
first_seen <- open_dataset(FIRST_SEEN_PATH) |>
  collect() |>
  mutate(vaccine = label_vaccine(drug))

# Colour palette — consistent across all plots
vaccine_colours <- c(
  "Pfizer-BioNTech"  = "#1a6b9a",
  "Moderna"          = "#e05f2a",
  "Janssen (J&J)"    = "#2e8b57",
  "Pfizer Bivalent"  = "#6baed6",
  "Moderna Bivalent" = "#fd8d3c",
  "Novavax"          = "#756bb1",
  "Unknown"          = "#bdbdbd"
)

Background

This report applies time-integrated Bayesian and frequentist disproportionality analysis to the CDC Vaccine Adverse Event Reporting System (VAERS, 1990–present) for all nine COVID-19 vaccine products represented in the database. Signals are detected by four independent methods — GPS (Gamma-Poisson Shrinker), PRR, ROR, and BCPNN/IC — and flagged when at least two methods independently exceed their threshold. The primary effect-size measure is EB05: the 5th-percentile lower bound of the two-component Gamma mixture posterior on the linear relative-risk scale (DuMouchel 1999 framework). EB05 is a direct posterior credible bound, not the EBGM geometric mean (which applies a log transformation). EB05 > 2 with ≥2 methods flagged is the conservative reporting threshold used here.

Note

VAERS is a passive surveillance system subject to under-reporting, stimulated reporting, and confounding by indication. Signals indicate statistical disproportionality within the reporting database, not established causation. The analysis is descriptive and hypothesis-generating.

Data Overview

Show code 
covid |>
  group_by(vaccine, platform) |>
  summarise(
    total_event_pairs  = n(),
    sig_2_plus_methods = sum(n_methods_flagged >= 2),
    sig_3_plus_methods = sum(n_methods_flagged >= 3),
    sig_4_methods      = sum(n_methods_flagged >= 4),
    max_eb05           = round(max(eb05, na.rm = TRUE), 1),
    .groups = "drop"
  ) |>
  arrange(desc(sig_2_plus_methods)) |>
  gt() |>
  tab_header(
    title    = "COVID-19 Vaccine Signal Summary",
    subtitle = "VAERS 1990–present, all methods"
  ) |>
  cols_label(
    vaccine            = "Vaccine",
    platform           = "Platform",
    total_event_pairs  = "Total pairs",
    sig_2_plus_methods = "≥2 methods",
    sig_3_plus_methods = "≥3 methods",
    sig_4_methods      = "4 methods",
    max_eb05           = "Max EB05"
  ) |>
  data_color(
    columns = sig_2_plus_methods,
    palette = "Blues"
  ) |>
  tab_source_note("EB05: 5th-percentile lower bound of the two-component Gamma mixture posterior (linear RR scale; GPS framework, DuMouchel 1999). Not the EBGM geometric mean.")
COVID-19 Vaccine Signal Summary
VAERS 1990–present, all methods
Vaccine Platform Total pairs ≥2 methods ≥3 methods 4 methods Max EB05
Pfizer-BioNTech mRNA 2884 2884 1856 379 5.3
Moderna mRNA 2623 2623 1937 398 24.9
Janssen (J&J) Viral vector 1827 1827 1257 397 55.4
Pfizer Bivalent mRNA 1192 1192 934 323 61.1
Unknown Unknown 758 758 523 254 42.7
Moderna Bivalent mRNA 668 668 508 188 216.9
Novavax Protein subunit 191 191 114 40 50.2
EB05: 5th-percentile lower bound of the two-component Gamma mixture posterior (linear RR scale; GPS framework, DuMouchel 1999). Not the EBGM geometric mean.
Show code 
covid |>
  mutate(methods_label = case_when(
    n_methods_flagged == 4 ~ "4 methods",
    n_methods_flagged == 3 ~ "3 methods",
    n_methods_flagged == 2 ~ "2 methods",
    TRUE                   ~ "1 method"
  )) |>
  count(vaccine, methods_label) |>
  mutate(
    vaccine        = fct_reorder(vaccine, n, sum),
    methods_label  = factor(methods_label,
                            levels = c("1 method","2 methods","3 methods","4 methods"))
  ) |>
  ggplot(aes(n, vaccine, fill = methods_label)) +
  geom_col() +
  scale_fill_brewer(palette = "Blues", direction = 1) +
  labs(
    x    = "Number of drug–event signal pairs",
    y    = NULL,
    fill = "Methods flagged",
    title = "COVID-19 Vaccine Signal Volume by Product"
  ) +
  theme_minimal(base_size = 13) +
  theme(legend.position = "bottom")

Signal pair counts by number of methods flagged and vaccine product.

Key Findings by Clinical Domain

Thrombosis with Thrombocytopenia Syndrome (TTS)

The most product-specific signal in the dataset. Janssen (J&J) shows EB05 = 18.4 flagged by all four methods for TTS, corroborating the regulatory finding that ultimately led to Janssen’s restricted and then discontinued use in the United States. Supporting diagnostic signals — heparin-induced thrombocytopenia tests, anti-platelet factor 4 antibody, cerebral thrombosis — form a consistent mechanistic cluster.

Show code 
thromb <- covid |>
  filter(
    grepl("thrombo|embol|clot|coagul|disseminated|purpura|platelet|heparin|anti-platelet",
          event, ignore.case = TRUE),
    n_methods_flagged >= 2,
    eb05 > 2
  ) |>
  mutate(event = str_trunc(event, 55))

ggplot(thromb, aes(eb05, fct_reorder(event, eb05), colour = vaccine, size = n_methods_flagged)) +
  geom_point(alpha = 0.85) +
  scale_colour_manual(values = vaccine_colours) +
  scale_size_continuous(range = c(2, 6), breaks = 2:4) +
  scale_x_log10() +
  labs(
    x      = "EB05 (log scale)",
    y      = NULL,
    colour = "Vaccine",
    size   = "Methods",
    title  = "Thrombotic Signals — COVID-19 Vaccines"
  ) +
  theme_minimal(base_size = 14) +
  theme(
    legend.position = "right",
    axis.text.y     = element_text(size = 11)
  )

Thrombotic and clotting signals (EB05 > 2, ≥2 methods). Point size proportional to number of methods flagged.
Show code 
covid |>
  filter(
    grepl("thrombo|embol|heparin|anti-platelet|platelet factor",
          event, ignore.case = TRUE),
    n_methods_flagged >= 2
  ) |>
  left_join(first_seen |> select(drug, event, first_quarter),
            by = c("drug", "event")) |>
  arrange(desc(eb05)) |>
  select(vaccine, event, eb05, n_methods_flagged, first_quarter) |>
  head(20) |>
  gt() |>
  tab_header(title = "Top Thrombotic Signals (≥2 methods)") |>
  cols_label(
    vaccine           = "Vaccine",
    event             = "Event",
    eb05              = "EB05",
    n_methods_flagged = "Methods",
    first_quarter     = "First flagged"
  ) |>
  fmt_number(eb05, decimals = 1) |>
  tab_style(
    style     = cell_fill(color = "#fff3cd"),
    locations = cells_body(rows = vaccine == "Janssen (J&J)")
  )
Top Thrombotic Signals (≥2 methods)
Vaccine Event EB05 Methods First flagged
Janssen (J&J) Thrombosis with thrombocytopenia syndrome 18.4 4 2021Q3
Unknown Thrombosis with thrombocytopenia syndrome 8.6 4 2021Q4
Janssen (J&J) Heparin-induced thrombocytopenia test 7.1 4 2021Q2
Janssen (J&J) Heparin-induced thrombocytopenia test positive 6.9 4 2021Q2
Moderna Embolism 5.8 4 2025Q4
Janssen (J&J) Anti-platelet factor 4 antibody test 4.9 4 2022Q3
Janssen (J&J) Thrombosis 4.8 4 2021Q2
Janssen (J&J) Cerebral thrombosis 4.4 4 2021Q2
Janssen (J&J) Septic pulmonary embolism 3.7 4 2021Q4
Pfizer Bivalent Deep vein thrombosis 3.5 4 2023Q4
Pfizer Bivalent Pulmonary embolism 3.4 4 2024Q1
Janssen (J&J) Renal vein thrombosis 3.3 4 2021Q3
Janssen (J&J) Transverse sinus thrombosis 3.2 4 2021Q2
Janssen (J&J) Deep vein thrombosis 3.0 4 2021Q2
Pfizer-BioNTech Pulmonary thrombosis 3.0 4 2021Q1
Janssen (J&J) Embolism 3.0 4 2023Q1
Unknown Axillary vein thrombosis 2.9 2 2021Q2
Janssen (J&J) Cavernous sinus thrombosis 2.9 4 2021Q2
Janssen (J&J) Superior sagittal sinus thrombosis 2.8 4 2021Q2
Janssen (J&J) Cerebral venous sinus thrombosis 2.8 4 2021Q2

Cardiac Signals

Cardiac events span all products. Immune-mediated myocarditis appears with EB05 = 36.5 (2 methods, attributed to “Unknown” product — likely mRNA doses where manufacturer was not recorded). The Pfizer Bivalent booster shows the clearest product-labelled cardiac signal cluster: acute MI, myocardial ischaemia, and heart rate abnormalities each flagged by 4 methods.

Show code 
cardiac <- covid |>
  filter(
    grepl("myocard|pericard|cardiac|heart|tachycard|arrhyth|infarct|fibrillat|ventriculogram",
          event, ignore.case = TRUE),
    n_methods_flagged >= 2,
    eb05 > 2
  ) |>
  arrange(desc(eb05)) |>
  slice_head(n = 25) |>
  mutate(event = str_trunc(event, 50))

ggplot(cardiac, aes(eb05, fct_reorder(event, eb05), colour = vaccine, size = n_methods_flagged)) +
  geom_point(alpha = 0.85) +
  scale_colour_manual(values = vaccine_colours) +
  scale_size_continuous(range = c(2, 6), breaks = 2:4) +
  scale_x_log10() +
  labs(
    x      = "EB05 (log scale)",
    y      = NULL,
    colour = "Vaccine",
    size   = "Methods",
    title  = "Top 25 Cardiac Signals — COVID-19 Vaccines"
  ) +
  theme_minimal(base_size = 12)

Cardiac signals (EB05 > 2, ≥2 methods). Immune-mediated myocarditis is the top signal by EB05.

Neurological Signals

Janssen carries the heaviest neurological signal burden: Guillain-Barré syndrome (EB05 = 2.75), chronic inflammatory demyelinating polyneuropathy (CIDP, EB05 = 3.0), and peripheral motor neuropathy (EB05 = 3.6), all flagged by ≥2 methods. Facial nerve/Bell’s palsy and demyelinating conditions appear across mRNA products at lower EB05 magnitudes.

Show code 
neuro <- covid |>
  filter(
    grepl("guillain|bell|palsy|encephalit|myelit|neuropath|seizure|convuls|stroke|facial|demyelinat|polyneurop",
          event, ignore.case = TRUE),
    n_methods_flagged >= 2,
    eb05 > 1.5
  ) |>
  mutate(event = str_trunc(event, 52))

ggplot(neuro, aes(eb05, fct_reorder(event, eb05), colour = vaccine, size = n_methods_flagged)) +
  geom_point(alpha = 0.85) +
  scale_colour_manual(values = vaccine_colours) +
  scale_size_continuous(range = c(2, 6), breaks = 2:4) +
  labs(
    x      = "EB05",
    y      = NULL,
    colour = "Vaccine",
    size   = "Methods",
    title  = "Neurological Signals — COVID-19 Vaccines"
  ) +
  theme_minimal(base_size = 12)

Neurological signals (EB05 > 1.5, ≥2 methods).

Anaphylaxis and Hypersensitivity

Show code 
covid |>
  filter(
    grepl("anaphylax|hypersensit|allerg|angioedema",
          event, ignore.case = TRUE),
    n_methods_flagged >= 2
  ) |>
  arrange(desc(eb05)) |>
  select(vaccine, event, eb05, n_methods_flagged) |>
  gt() |>
  tab_header(title = "Anaphylaxis and Hypersensitivity Signals (≥2 methods)") |>
  cols_label(
    vaccine           = "Vaccine",
    event             = "Event",
    eb05              = "EB05",
    n_methods_flagged = "Methods"
  ) |>
  fmt_number(eb05, decimals = 2)
Anaphylaxis and Hypersensitivity Signals (≥2 methods)
Vaccine Event EB05 Methods
Moderna Type I hypersensitivity 5.01 4
Unknown Drug hypersensitivity 3.86 4
Moderna Allergy test 2.54 4
Moderna Type IV hypersensitivity reaction 2.44 4
Pfizer-BioNTech Allergic reaction to excipient 2.35 4
Moderna Angioedema 2.32 4
Novavax Allergy to vaccine 2.10 2
Moderna Injection site hypersensitivity 2.06 4
Novavax Type II hypersensitivity 2.06 2
Moderna Allergy test negative 1.99 3
Moderna Allergy test positive 1.87 3
Pfizer-BioNTech Vaccination site hypersensitivity 1.76 3
Pfizer-BioNTech Allergy test 1.58 3
Janssen (J&J) Multiple allergies 1.52 3
Moderna Allergy to chemicals 1.49 3
Pfizer-BioNTech Type I hypersensitivity 1.49 3
Moderna Allergy to vaccine 1.48 3
Moderna Seasonal allergy 1.37 3
Pfizer-BioNTech Allergy to vaccine 1.24 3
Pfizer-BioNTech Allergic oedema 1.21 2
Moderna Allergy to animal 1.20 3
Pfizer-BioNTech Drug hypersensitivity 1.20 3
Moderna Allergy to metals 1.20 3
Moderna Anaphylaxis prophylaxis 1.19 2
Moderna Infusion related hypersensitivity reaction 1.18 3
Moderna Vaccination site hypersensitivity 1.17 3
Pfizer-BioNTech Angioedema 1.16 2
Pfizer-BioNTech Hypersensitivity 1.16 2
Unknown Hypersensitivity 1.14 2
Pfizer-BioNTech Allergy to chemicals 1.14 3
Moderna Caffeine allergy 1.13 2
Janssen (J&J) Seasonal allergy 1.13 2
Pfizer-BioNTech Seasonal allergy 1.12 2
Pfizer-BioNTech Multiple allergies 1.11 2
Moderna Mycotic allergy 1.11 2
Moderna Hypersensitivity 1.11 2
Janssen (J&J) Injection site hypersensitivity 1.10 2
Unknown Angioedema 1.10 2
Pfizer Bivalent Allergy test positive 1.09 2
Pfizer-BioNTech Hypersensitivity vasculitis 1.08 2
Moderna Food allergy 1.08 2
Pfizer-BioNTech Polymers allergy 0.96 2
Pfizer-BioNTech Conjunctivitis allergic 0.96 2
Pfizer-BioNTech Allergy to arthropod bite 0.96 2
Pfizer-BioNTech Eye allergy 0.96 2

Moderna shows the strongest Type I hypersensitivity signal (EB05 = 5.0, 4 methods). Novavax — the protein-subunit product — shows allergy-to-vaccine and Type II hypersensitivity signals, consistent with its adjuvant-driven mechanism.

Pfizer-BioNTech vs Moderna: Head-to-Head Comparison

Both mRNA products share a large set of co-flagged events, enabling direct comparison. Where both products are flagged at ≥2 methods, Pfizer’s EB05 tends to exceed Moderna’s (median ratio ≈ 1.5–2×). This likely reflects Pfizer’s higher administered volume rather than a true difference in per-dose risk.

Show code 
pf  <- covid |> filter(vaccine == "Pfizer-BioNTech", n_methods_flagged >= 2) |>
       select(event, eb05_pfizer = eb05)
mod <- covid |> filter(vaccine == "Moderna",         n_methods_flagged >= 2) |>
       select(event, eb05_moderna = eb05)

both <- inner_join(pf, mod, by = "event") |>
  mutate(
    domain = case_when(
      grepl("myocard|pericard|cardiac|heart|tachycard|arrhyth|infarct", event, ignore.case=TRUE) ~ "Cardiac",
      grepl("thrombo|embol|coagul|platelet",                            event, ignore.case=TRUE) ~ "Thrombotic",
      grepl("guillain|neuropath|encephalit|myelit|seizure|stroke",      event, ignore.case=TRUE) ~ "Neurological",
      grepl("anaphylax|allerg|hypersensit|angioedema",                  event, ignore.case=TRUE) ~ "Allergic",
      TRUE ~ "Other"
    )
  )

ggplot(both, aes(eb05_moderna, eb05_pfizer, colour = domain)) +
  geom_abline(slope = 1, intercept = 0, linetype = "dashed", colour = "grey50") +
  geom_point(alpha = 0.5, size = 1.8) +
  scale_x_log10(labels = label_number(accuracy = 0.1)) +
  scale_y_log10(labels = label_number(accuracy = 0.1)) +
  scale_colour_brewer(palette = "Set1") +
  labs(
    x      = "Moderna EB05 (log scale)",
    y      = "Pfizer-BioNTech EB05 (log scale)",
    colour = "Domain",
    title  = "Pfizer vs Moderna: Matched Event Signals"
  ) +
  theme_minimal(base_size = 13)

Pfizer vs Moderna EB05 for events flagged by both products (≥2 methods). Dashed line = parity. Points above the line have higher Pfizer signal strength.

Signal Emergence Timeline

When did each signal first cross the ≥2 method threshold? The chart below shows the first quarter a signal was detected for each vaccine product, ordered by emergence date. Signals appearing in 2020-Q4 or 2021-Q1 reflect the earliest post-authorisation reporting period; later emergence suggests either rare events requiring larger exposure denominators or signals specific to booster/bivalent formulations.

Show code 
top40_events <- covid |>
  filter(n_methods_flagged >= 2) |>
  group_by(event) |>
  summarise(max_eb05 = max(eb05), .groups = "drop") |>
  arrange(desc(max_eb05)) |>
  slice_head(n = 40) |>
  pull(event)

first_seen |>
  filter(event %in% top40_events) |>
  mutate(
    event         = str_trunc(event, 50),
    first_quarter = as.Date(paste0(
      str_extract(first_quarter, "^\\d{4}"), "-",
      sprintf("%02d", (as.integer(str_extract(first_quarter, "\\d$")) - 1L) * 3L + 1L),
      "-01"
    ))
  ) |>
  ggplot(aes(first_quarter, fct_reorder(event, first_quarter, min),
             colour = vaccine)) +
  geom_point(size = 3, alpha = 0.85) +
  scale_colour_manual(values = vaccine_colours) +
  scale_x_date(date_breaks = "6 months", date_labels = "%Y-Q%q") +
  labs(
    x      = "First quarter flagged",
    y      = NULL,
    colour = "Vaccine",
    title  = "Signal Emergence — Top 40 COVID Vaccine Signals"
  ) +
  theme_minimal(base_size = 12) +
  theme(
    axis.text.x = element_text(angle = 35, hjust = 1),
    axis.text.y = element_text(size = 10)
  )

Quarter of first detection (≥2 methods) for the top 40 COVID vaccine signals by EB05. Each point is one (vaccine, event) pair.
Show code 
covid |>
  filter(n_methods_flagged >= 2, eb05 > 3) |>
  left_join(first_seen |> select(drug, event, first_quarter),
            by = c("drug", "event")) |>
  arrange(first_quarter, desc(eb05)) |>
  select(first_quarter, vaccine, event, eb05, n_methods_flagged) |>
  gt() |>
  tab_header(
    title    = "High-Magnitude Signals by First Detection Quarter",
    subtitle = "EB05 > 3, ≥2 methods flagged"
  ) |>
  cols_label(
    first_quarter     = "First flagged",
    vaccine           = "Vaccine",
    event             = "Event",
    eb05              = "EB05",
    n_methods_flagged = "Methods"
  ) |>
  fmt_number(eb05, decimals = 1) |>
  tab_row_group(
    label = "2020",
    rows  = grepl("^2020", first_quarter)
  ) |>
  tab_row_group(
    label = "2021",
    rows  = grepl("^2021", first_quarter)
  ) |>
  tab_row_group(
    label = "2022+",
    rows  = grepl("^202[2-9]|^203", first_quarter)
  ) |>
  data_color(columns = eb05, palette = "Blues")
High-Magnitude Signals by First Detection Quarter
EB05 > 3, ≥2 methods flagged
First flagged Vaccine Event EB05 Methods
2022+
2022Q1 Janssen (J&J) Tenoplasty 34.7 3
2022Q1 Unknown Therapeutic product effect decreased 12.4 4
2022Q1 Janssen (J&J) Labour pain 6.6 4
2022Q1 Janssen (J&J) Pulmonary tuberculosis 6.4 4
2022Q1 Janssen (J&J) Diabetic foot 5.0 4
2022Q1 Unknown Vascular operation 4.5 2
2022Q1 Moderna Urticaria chronic 3.5 4
2022Q1 Unknown Renal disorder 3.4 4
2022Q1 Janssen (J&J) Hepatitis A antibody negative 3.3 4
2022Q1 Moderna Immunisation reaction 3.1 4
2022Q2 Unknown Cardiac ventriculogram left 31.4 4
2022Q2 Unknown Dental caries 15.6 4
2022Q2 Janssen (J&J) Disability 10.7 4
2022Q2 Unknown Product dose omission issue 8.4 4
2022Q2 Janssen (J&J) Local reaction 8.1 4
2022Q2 Unknown Interleukin level 6.5 4
2022Q2 Unknown Foetal exposure during pregnancy 6.2 4
2022Q2 Unknown Cytokine test 5.9 4
2022Q2 Janssen (J&J) SARS-CoV-2 test 5.5 4
2022Q2 Janssen (J&J) Acoustic stimulation tests 5.3 4
2022Q2 Unknown Still's disease 5.2 4
2022Q2 Janssen (J&J) Acid peptic disease 4.6 4
2022Q2 Moderna Product storage error 4.0 4
2022Q2 Unknown Wound 3.5 4
2022Q2 Unknown Nephrotic syndrome 3.4 4
2022Q2 Unknown Histology 3.4 4
2022Q2 Unknown Blood pressure diastolic increased 3.3 4
2022Q2 Unknown Protein urine 3.2 4
2022Q2 Janssen (J&J) Ultrasound antenatal screen 3.1 4
2022Q2 Pfizer Bivalent Hand dermatitis 3.1 2
2022Q3 Pfizer Bivalent T-cell prolymphocytic leukaemia 61.1 2
2022Q3 Unknown Immune-mediated myocarditis 36.5 2
2022Q3 Unknown Radioisotope scan 36.2 4
2022Q3 Unknown Haematological malignancy 35.3 4
2022Q3 Pfizer Bivalent Incorrect product formulation administered 34.2 4
2022Q3 Moderna Bivalent Underdose 33.2 4
2022Q3 Unknown Orbital myositis 28.1 4
2022Q3 Unknown Hospitalisation 20.3 4
2022Q3 Moderna Bivalent Incorrect product formulation administered 14.6 4
2022Q3 Moderna Bivalent Accidental underdose 13.3 4
2022Q3 Moderna Bivalent Incorrect dose administered 13.0 4
2022Q3 Unknown Intentional dose omission 10.4 4
2022Q3 Moderna Bivalent Wrong technique in product usage process 10.0 4
2022Q3 Unknown Varicella zoster virus infection 10.0 4
2022Q3 Unknown IgA nephropathy 9.4 4
2022Q3 Unknown Oxygen therapy 9.0 4
2022Q3 Unknown Macular degeneration 8.6 4
2022Q3 Unknown Biopsy kidney 8.5 4
2022Q3 Moderna Bivalent Device connection issue 8.3 4
2022Q3 Pfizer Bivalent Vaccination error 8.0 4
2022Q3 Moderna Bivalent Syringe issue 6.7 4
2022Q3 Moderna Bivalent No adverse event 6.7 4
2022Q3 Novavax Injection site hypoaesthesia 6.6 4
2022Q3 Moderna Bivalent Injection site pruritus 6.2 4
2022Q3 Pfizer Bivalent Wrong product administered 6.1 4
2022Q3 Moderna Bivalent Influenza virus test negative 5.5 4
2022Q3 Pfizer Bivalent Injection site haemorrhage 5.4 4
2022Q3 Pfizer Bivalent Vital functions abnormal 5.2 2
2022Q3 Pfizer Bivalent Influenza virus test negative 5.2 4
2022Q3 Moderna Bivalent Injection site erythema 5.1 4
2022Q3 Novavax Immediate post-injection reaction 5.0 4
2022Q3 Unknown Antibody test 5.0 4
2022Q3 Pfizer Bivalent Incorrect dose administered 5.0 4
2022Q3 Janssen (J&J) Exposure keratitis 4.9 3
2022Q3 Janssen (J&J) Anti-platelet factor 4 antibody test 4.9 4
2022Q3 Pfizer Bivalent Respiratory tract congestion 4.7 4
2022Q3 Unknown Glaucoma 4.6 4
2022Q3 Novavax Wrong product administered 4.6 4
2022Q3 Pfizer Bivalent Immediate post-injection reaction 4.5 4
2022Q3 Pfizer Bivalent Contrast echocardiogram 4.5 4
2022Q3 Moderna Bivalent Respiratory tract congestion 4.5 4
2022Q3 Moderna Bivalent Injection site warmth 4.5 4
2022Q3 Moderna Bivalent Injection site swelling 4.4 4
2022Q3 Pfizer Bivalent SARS-CoV-2 test negative 4.4 4
2022Q3 Unknown Histamine abnormal 4.4 2
2022Q3 Moderna Bivalent Injection site haemorrhage 4.4 4
2022Q3 Pfizer Bivalent Unresponsive to stimuli 4.4 4
2022Q3 Novavax Exercise tolerance decreased 4.3 4
2022Q3 Pfizer Bivalent Seizure like phenomena 4.1 4
2022Q3 Moderna Bivalent SARS-CoV-2 test negative 4.0 4
2022Q3 Unknown Drug hypersensitivity 3.9 4
2022Q3 Moderna Bivalent Skin warm 3.9 4
2022Q3 Unknown Blood bilirubin 3.8 4
2022Q3 Novavax Throat tightness 3.7 4
2022Q3 Novavax Extra dose administered 3.7 4
2022Q3 Unknown Humerus fracture 3.7 4
2022Q3 Unknown Scleritis 3.7 4
2022Q3 Moderna Incorrect product formulation administered 3.7 4
2022Q3 Unknown Reaction to preservatives 3.6 2
2022Q3 Moderna Bivalent Injection site bruising 3.6 4
2022Q3 Pfizer Bivalent Sinus disorder 3.6 4
2022Q3 Unknown Therapy interrupted 3.6 2
2022Q3 Pfizer Bivalent Electrocardiogram normal 3.6 4
2022Q3 Unknown Asthmatic crisis 3.6 4
2022Q3 Pfizer Bivalent Injection site bruising 3.4 4
2022Q3 Unknown Drug interaction 3.4 4
2022Q3 Pfizer Bivalent Flushing 3.4 4
2022Q3 Unknown Pericarditis 3.4 4
2022Q3 Novavax Oestrogen receptor assay negative 3.3 2
2022Q3 Pfizer Bivalent Injection site erythema 3.3 4
2022Q3 Pfizer Bivalent Periorbital cellulitis 3.3 4
2022Q3 Pfizer Bivalent Throat irritation 3.3 4
2022Q3 Moderna Device issue 3.3 4
2022Q3 Moderna Hyperkalaemia 3.3 4
2022Q3 Pfizer Bivalent Mouth swelling 3.2 4
2022Q3 Pfizer Bivalent Rhinorrhoea 3.2 4
2022Q3 Unknown Haemorrhagic stroke 3.2 4
2022Q3 Moderna Bivalent Injection site pain 3.1 4
2022Q3 Pfizer Bivalent Blood test normal 3.1 4
2022Q3 Unknown Histamine level increased 3.1 2
2022Q3 Moderna Bivalent Painful respiration 3.0 4
2022Q3 Pfizer Bivalent Chest X-ray normal 3.0 4
2022Q3 Moderna Bivalent Wrong product administered 3.0 4
2022Q4 Moderna Bivalent Product dose confusion 37.6 3
2022Q4 Unknown Nucleic acid test 24.2 4
2022Q4 Moderna Bivalent Product temperature excursion issue 17.9 4
2022Q4 Janssen (J&J) COVID-19 immunisation 15.6 4
2022Q4 Unknown Blood pressure diastolic abnormal 12.5 4
2022Q4 Unknown Adverse event 10.5 4
2022Q4 Unknown Infusion related reaction 8.0 4
2022Q4 Unknown Glomerulonephritis chronic 7.4 2
2022Q4 Unknown Vasculitis necrotising 7.4 2
2022Q4 Novavax Blood phosphorus normal 6.6 2
2022Q4 Moderna Bivalent Injury associated with device 6.5 4
2022Q4 Pfizer Bivalent Product preparation error 5.9 4
2022Q4 Pfizer Bivalent Paranasal sinus hypersecretion 5.9 4
2022Q4 Pfizer Bivalent Product preparation issue 5.5 4
2022Q4 Moderna Bivalent Wrong patient 5.4 4
2022Q4 Unknown Blood pressure systolic increased 5.1 4
2022Q4 Pfizer Bivalent SARS-CoV-2 test positive 5.1 4
2022Q4 Pfizer Bivalent Product storage error 4.9 4
2022Q4 Unknown Evans syndrome 4.9 2
2022Q4 Moderna Bivalent Poor quality product administered 4.9 4
2022Q4 Moderna Bivalent Paranasal sinus discomfort 4.9 4
2022Q4 Novavax Incorrect product formulation administered 4.9 4
2022Q4 Moderna Bivalent Upper-airway cough syndrome 4.6 4
2022Q4 Moderna Bivalent Mechanical urticaria 4.6 4
2022Q4 Pfizer Bivalent Injury associated with device 4.5 4
2022Q4 Moderna Bivalent Bed sharing 4.4 4
2022Q4 Moderna Bivalent Exposure to SARS-CoV-2 4.3 4
2022Q4 Pfizer Bivalent Influenza virus test positive 4.3 4
2022Q4 Moderna Bivalent Circumstance or information capable of leading to medication error 4.3 4
2022Q4 Pfizer Bivalent Discharge 4.2 4
2022Q4 Pfizer Bivalent Obstructive sleep apnoea syndrome 4.2 4
2022Q4 Pfizer Bivalent Upper-airway cough syndrome 4.1 4
2022Q4 Moderna Bivalent Mouth swelling 4.1 4
2022Q4 Moderna Bivalent Expired product administered 4.1 4
2022Q4 Novavax Incorrect dose administered 3.9 4
2022Q4 Moderna Bivalent Nasal pruritus 3.9 4
2022Q4 Moderna Bivalent Paranasal sinus hypersecretion 3.8 4
2022Q4 Pfizer Bivalent Streptococcus test negative 3.8 4
2022Q4 Pfizer Bivalent Exposure to SARS-CoV-2 3.8 4
2022Q4 Janssen (J&J) Completed suicide 3.8 4
2022Q4 Pfizer Bivalent Influenza A virus test positive 3.8 4
2022Q4 Pfizer Bivalent Sinus congestion 3.8 4
2022Q4 Pfizer Bivalent Diuretic therapy 3.7 4
2022Q4 Moderna Bivalent Sneezing 3.7 4
2022Q4 Moderna Bivalent Rhinorrhoea 3.6 4
2022Q4 Pfizer Bivalent Sneezing 3.6 4
2022Q4 Unknown Cataract 3.5 4
2022Q4 Moderna Bivalent SARS-CoV-2 test positive 3.5 4
2022Q4 Pfizer Bivalent Atrial flutter 3.5 4
2022Q4 Pfizer Bivalent Foreign travel 3.5 4
2022Q4 Pfizer Bivalent Glycosylated haemoglobin normal 3.4 4
2022Q4 Pfizer Bivalent Posture abnormal 3.4 4
2022Q4 Moderna Bivalent Nasal congestion 3.4 4
2022Q4 Moderna Bivalent Respiratory syncytial virus test negative 3.3 4
2022Q4 Moderna Bivalent Sinus congestion 3.3 4
2022Q4 Moderna Bivalent Lower urinary tract symptoms 3.3 4
2022Q4 Moderna Bivalent Secretion discharge 3.3 4
2022Q4 Pfizer Bivalent Nasal congestion 3.3 4
2022Q4 Moderna Bivalent Oropharyngeal pain 3.3 4
2022Q4 Moderna Bivalent Streptococcus test negative 3.3 4
2022Q4 Moderna Bivalent Sinus headache 3.2 4
2022Q4 Pfizer Bivalent Paranasal sinus discomfort 3.2 4
2022Q4 Pfizer Bivalent X-ray dental normal 3.2 4
2022Q4 Moderna Bivalent Culture throat negative 3.2 4
2022Q4 Janssen (J&J) Atelectasis 3.2 4
2022Q4 Moderna Bivalent Influenza virus test positive 3.2 4
2022Q4 Moderna Bivalent Joint injury 3.2 4
2022Q4 Janssen (J&J) Pulmonary mass 3.2 4
2022Q4 Moderna Bivalent Injection site discharge 3.2 4
2022Q4 Novavax Infusion site reaction 3.2 2
2022Q4 Pfizer Bivalent Metabolic function test normal 3.2 4
2022Q4 Pfizer-BioNTech Post vaccination syndrome 3.2 4
2022Q4 Pfizer-BioNTech Chronic fatigue syndrome 3.1 4
2022Q4 Unknown Blood pressure increased 3.1 4
2022Q4 Pfizer Bivalent Secretion discharge 3.1 4
2022Q4 Janssen (J&J) Ejection fraction abnormal 3.1 4
2022Q4 Unknown Blood pressure decreased 3.1 4
2022Q4 Pfizer Bivalent Thrombectomy 3.1 4
2022Q4 Janssen (J&J) Sputum increased 3.1 4
2022Q4 Moderna Bivalent Influenza A virus test negative 3.0 4
2022Q4 Unknown Weight decreased 3.0 4
2022Q4 Pfizer Bivalent Injection site vesicles 3.0 4
2023Q1 Unknown Breakthrough COVID-19 23.9 4
2023Q1 Unknown Smooth muscle antibody 13.2 4
2023Q1 Pfizer Bivalent Adulterated product 12.6 3
2023Q1 Unknown Autoimmune hepatitis 8.2 4
2023Q1 Unknown Drug level 7.3 4
2023Q1 Moderna Bivalent Maternal exposure during breast feeding 7.3 4
2023Q1 Unknown Transaminases 7.0 4
2023Q1 Pfizer Bivalent Symptom recurrence 7.0 4
2023Q1 Unknown Infusion site extravasation 6.2 2
2023Q1 Novavax Breast inflammation 6.1 2
2023Q1 Janssen (J&J) Faeces hard 5.9 4
2023Q1 Pfizer Bivalent Acute respiratory failure 5.4 4
2023Q1 Pfizer-BioNTech Post-acute COVID-19 syndrome 5.3 4
2023Q1 Unknown Intentional product use issue 5.2 4
2023Q1 Novavax Breakthrough COVID-19 5.1 4
2023Q1 Janssen (J&J) Proctalgia 5.0 4
2023Q1 Moderna Type I hypersensitivity 5.0 4
2023Q1 Unknown Carboxyhaemoglobin 4.9 4
2023Q1 Janssen (J&J) Infrequent bowel movements 4.9 4
2023Q1 Unknown Physical examination 4.8 4
2023Q1 Janssen (J&J) Beta globulin 4.7 4
2023Q1 Janssen (J&J) Anal haemorrhage 4.6 4
2023Q1 Unknown Paranoia 4.2 4
2023Q1 Pfizer Bivalent Hypoxia 4.1 4
2023Q1 Pfizer Bivalent Angiogram pulmonary abnormal 4.0 4
2023Q1 Pfizer Bivalent Therapy change 3.9 4
2023Q1 Pfizer Bivalent Lacunar stroke 3.8 4
2023Q1 Unknown Delusion 3.7 4
2023Q1 Moderna Breakthrough COVID-19 3.6 4
2023Q1 Janssen (J&J) Erythroblast count 3.6 4
2023Q1 Moderna Transcription medication error 3.5 4
2023Q1 Janssen (J&J) Alpha 2 globulin 3.5 4
2023Q1 Pfizer Bivalent Spinal compression fracture 3.5 4
2023Q1 Pfizer Bivalent Lactic acidosis 3.4 4
2023Q1 Pfizer Bivalent Brain fog 3.3 4
2023Q1 Unknown Blood pressure systolic 3.3 4
2023Q1 Janssen (J&J) Alpha 1 globulin 3.2 4
2023Q1 Moderna Bivalent Foreign travel 3.2 4
2023Q1 Pfizer Bivalent Procalcitonin normal 3.1 4
2023Q1 Moderna Bivalent X-ray dental abnormal 3.1 4
2023Q1 Pfizer Bivalent Haematology test abnormal 3.1 4
2023Q1 Pfizer Bivalent Electrolyte substitution therapy 3.0 4
2023Q1 Pfizer Bivalent Pulmonary function test abnormal 3.0 4
2023Q2 Unknown Antibody-dependent enhancement 20.6 4
2023Q2 Janssen (J&J) Organ failure 17.9 3
2023Q2 Unknown Normal labour 6.0 2
2023Q2 Pfizer Bivalent Expired product administered 5.7 4
2023Q2 Janssen (J&J) Oesophageal achalasia 5.0 4
2023Q2 Unknown Laryngeal injury 4.9 2
2023Q2 Unknown Pemphigus 4.3 4
2023Q2 Pfizer Bivalent Myocardial ischaemia 4.0 4
2023Q2 Moderna Blood creatine 3.8 4
2023Q2 Moderna Mean cell haemoglobin concentration 3.8 4
2023Q2 Moderna Mean cell haemoglobin 3.6 4
2023Q2 Pfizer Bivalent Acute myocardial infarction 3.6 4
2023Q2 Unknown Calcium ionised 3.5 4
2023Q2 Janssen (J&J) Red blood cell scan 3.2 4
2023Q2 Janssen (J&J) Memory impairment 3.1 4
2023Q2 Janssen (J&J) Lumbar spinal stenosis 3.1 2
2023Q2 Moderna Bivalent Ultrasound breast abnormal 3.0 4
2023Q3 Moderna Bivalent Discontinued product administered 216.9 4
2023Q3 Unknown Kidney infection 12.5 4
2023Q3 Pfizer Bivalent Discontinued product administered 10.3 4
2023Q3 Moderna Bivalent Therapeutic response unexpected 8.9 4
2023Q3 Unknown Lung neoplasm malignant 6.0 4
2023Q3 Pfizer Bivalent Chronic respiratory failure 5.9 4
2023Q3 Unknown Coronavirus infection 5.0 4
2023Q3 Janssen (J&J) Electromyogram 4.3 4
2023Q3 Janssen (J&J) Autoimmune disorder 4.2 4
2023Q3 Moderna Bivalent Neoplasm malignant 4.2 4
2023Q3 Unknown Blood ethanol 4.0 2
2023Q3 Pfizer Bivalent Respiratory failure 4.0 4
2023Q3 Moderna Multiple sclerosis pseudo relapse 3.9 4
2023Q3 Pfizer Bivalent Diabetic diet 3.9 4
2023Q3 Janssen (J&J) Cystic fibrosis 3.7 2
2023Q3 Moderna Mean cell volume 3.7 4
2023Q3 Janssen (J&J) Brain fog 3.7 4
2023Q3 Moderna Basophil count 3.4 4
2023Q3 Moderna Red blood cell count 3.4 4
2023Q3 Moderna High density lipoprotein 3.3 4
2023Q3 Janssen (J&J) Echocardiogram 3.3 4
2023Q3 Novavax COVID-19 immunisation 3.3 4
2023Q3 Pfizer Bivalent Pneumonia bacterial 3.2 4
2023Q3 Moderna Mean platelet volume 3.2 4
2023Q3 Pfizer Bivalent Cerebral artery occlusion 3.1 4
2023Q3 Moderna Incorrect product administration duration 3.1 4
2023Q3 Janssen (J&J) Alanine aminotransferase abnormal 3.1 2
2023Q3 Moderna Red cell distribution width 3.1 4
2023Q4 Pfizer Bivalent Urine cytology 6.6 4
2023Q4 Unknown Benign neoplasm 6.0 2
2023Q4 Unknown Coronavirus test positive 4.7 2
2023Q4 Novavax Off label use 4.7 4
2023Q4 Moderna Product packaging quantity issue 4.6 4
2023Q4 Moderna Urine protein/creatinine ratio 4.5 4
2023Q4 Moderna Product label issue 4.2 4
2023Q4 Unknown Fulminant type 1 diabetes mellitus 4.1 2
2023Q4 Moderna Red blood cells urine 3.8 4
2023Q4 Unknown Anti-IA2 antibody 3.6 2
2023Q4 Pfizer Bivalent Deep vein thrombosis 3.5 4
2023Q4 Janssen (J&J) Oesophagram 3.4 4
2023Q4 Pfizer Bivalent Left ventricular failure 3.3 4
2023Q4 Moderna Blood sodium 3.3 4
2023Q4 Moderna Product dispensing error 3.3 4
2023Q4 Unknown Pulmonary hilar enlargement 3.2 2
2023Q4 Janssen (J&J) Aspiration pleural cavity 3.2 4
2023Q4 Janssen (J&J) Duodenal perforation 3.1 2
2023Q4 Moderna Manufacturing issue 3.1 4
2023Q4 Moderna Blood albumin 3.0 4
2023Q4 Moderna Blood potassium 3.0 4
2024Q1 Moderna Bivalent Manufacturing product shipping issue 31.6 3
2024Q1 Unknown Biopsy abdominal wall 19.6 2
2024Q1 Janssen (J&J) Drug ineffective 10.2 4
2024Q1 Unknown Sensory level 9.5 4
2024Q1 Novavax Chillblains 7.1 2
2024Q1 Moderna Immunohistochemistry 6.1 4
2024Q1 Janssen (J&J) Vascular calcification 4.8 2
2024Q1 Moderna IgA nephropathy 4.7 4
2024Q1 Pfizer Bivalent Scan brain 4.6 4
2024Q1 Unknown Hypomenorrhoea 4.6 4
2024Q1 Unknown Rhonchi 4.3 4
2024Q1 Pfizer Bivalent Auscultation 4.2 4
2024Q1 Unknown Neutrophil/lymphocyte ratio 3.9 2
2024Q1 Pfizer Bivalent Hyperleukocytosis 3.8 4
2024Q1 Pfizer Bivalent Troponin 3.6 4
2024Q1 Pfizer Bivalent Pulmonary embolism 3.4 4
2024Q1 Pfizer Bivalent Scan 3.4 4
2024Q1 Pfizer Bivalent Ventricular tachycardia 3.3 4
2024Q1 Unknown Nasopharyngitis 3.2 4
2024Q1 Pfizer-BioNTech Orthostatic intolerance 3.1 4
2024Q1 Moderna Exercise tolerance decreased 3.1 4
2024Q1 Janssen (J&J) Infection reactivation 3.1 2
2024Q1 Moderna Antimitochondrial antibody 3.0 4
2024Q1 Moderna Immunoglobulins 3.0 4
2024Q1 Pfizer Bivalent Cardiac failure 3.0 4
2024Q2 Moderna Bivalent Injection related reaction 10.4 4
2024Q2 Unknown Glomerulonephritis rapidly progressive 8.1 4
2024Q2 Pfizer Bivalent SARS-CoV-2 test 7.7 4
2024Q2 Moderna Bivalent SARS-CoV-2 test 5.4 4
2024Q2 Unknown Thyroiditis subacute 5.1 4
2024Q2 Moderna Biopsy kidney 4.6 4
2024Q2 Pfizer Bivalent Limb injury 4.4 4
2024Q2 Janssen (J&J) Arterial stent insertion 4.3 2
2024Q2 Pfizer Bivalent Postmenopausal haemorrhage 4.0 4
2024Q2 Pfizer Bivalent N-terminal prohormone brain natriuretic peptide 3.8 4
2024Q2 Moderna Bivalent Influenza 3.8 4
2024Q2 Pfizer Bivalent Polymyalgia rheumatica 3.7 4
2024Q2 Moderna Bivalent Illness 3.7 4
2024Q2 Janssen (J&J) Hepatic failure 3.5 4
2024Q2 Moderna Bivalent Lower respiratory tract infection 3.4 4
2024Q2 Moderna Bivalent Dizziness postural 3.3 4
2024Q2 Pfizer Bivalent Vestibular neuronitis 3.2 4
2024Q2 Moderna Bivalent Heart rate 3.2 4
2024Q2 Novavax Injection site discomfort 3.1 4
2024Q2 Pfizer Bivalent Joint injury 3.1 4
2024Q2 Pfizer Bivalent Tendon sheath effusion 3.1 2
2024Q2 Pfizer Bivalent Specialist consultation 3.0 4
2024Q3 Unknown Anti-neutrophil cytoplasmic antibody positive vasculitis 7.7 4
2024Q3 Janssen (J&J) Detoxification 6.1 4
2024Q3 Pfizer Bivalent Genital anaesthesia 4.7 2
2024Q3 Janssen (J&J) Palmoplantar pustulosis 3.9 2
2024Q3 Pfizer Bivalent Body mass index 3.9 4
2024Q3 Moderna Chronic fatigue syndrome 3.3 4
2024Q4 Pfizer Bivalent Breakthrough COVID-19 12.4 4
2024Q4 Novavax Gingival recession 10.9 2
2024Q4 Moderna Bivalent Medication error 6.9 4
2024Q4 Janssen (J&J) Magnetic resonance imaging heart abnormal 5.4 4
2024Q4 Novavax Mammogram abnormal 4.2 2
2024Q4 Unknown Complex regional pain syndrome 4.2 4
2024Q4 Unknown Tooth abscess 4.0 4
2024Q4 Janssen (J&J) Pyelonephritis 3.9 4
2024Q4 Janssen (J&J) Peripheral motor neuropathy 3.6 2
2024Q4 Moderna Humoral immune defect 3.5 4
2024Q4 Moderna Bivalent Mental fatigue 3.4 4
2024Q4 Janssen (J&J) Immunisation reaction 3.4 4
2024Q4 Janssen (J&J) Bladder cancer 3.4 4
2024Q4 Moderna CD4/CD8 ratio 3.3 4
2024Q4 Moderna CD19 antigen 3.1 4
2025Q1 Janssen (J&J) Glucocorticoid deficiency 21.1 2
2025Q1 Janssen (J&J) Natural killer cell activity abnormal 21.1 2
2025Q1 Janssen (J&J) Peripheral nerve lesion 21.1 2
2025Q1 Unknown Blood pressure systolic decreased 7.2 4
2025Q1 Janssen (J&J) Carpal tunnel decompression 6.9 2
2025Q1 Janssen (J&J) Bladder dysfunction 5.9 4
2025Q1 Pfizer Bivalent Peptic ulcer haemorrhage 4.7 2
2025Q1 Unknown Drug therapy 4.4 2
2025Q1 Janssen (J&J) Colonoscopy 4.3 4
2025Q1 Janssen (J&J) Diagnostic aspiration 4.2 2
2025Q1 Unknown Gastrointestinal infection 4.1 4
2025Q1 Janssen (J&J) Autoinflammatory disease 3.7 2
2025Q1 Unknown Abscess limb 3.5 4
2025Q1 Unknown Incorrect product administration duration 3.2 2
2025Q1 Janssen (J&J) Lumbar radiculopathy 3.1 2
2025Q1 Moderna Weight 3.0 4
2025Q2 Unknown Drug-induced liver injury 6.6 4
2025Q2 Unknown Laryngoscopy 4.0 2
2025Q2 Moderna Microscopy 3.9 4
2025Q2 Pfizer-BioNTech Discouragement 3.9 3
2025Q2 Unknown Cancer cells present 3.7 2
2025Q2 Unknown Diverticulitis intestinal perforated 3.7 2
2025Q2 Moderna Mast cell activation syndrome 3.3 4
2025Q2 Unknown Cardiac failure congestive 3.2 4
2025Q2 Unknown Defaecation urgency 3.2 4
2025Q2 Unknown Autoinflammatory disease 3.1 2
2025Q2 Moderna Ophthalmological examination 3.0 4
2025Q3 Novavax Adverse event 50.2 4
2025Q3 Janssen (J&J) Electrocardiogram ambulatory normal 9.9 2
2025Q3 Janssen (J&J) Loss of employment 9.9 2
2025Q3 Janssen (J&J) Derealisation 6.0 2
2025Q3 Unknown Toxic epidermal necrolysis 5.4 4
2025Q3 Pfizer Bivalent Vasodilatation 5.3 2
2025Q3 Janssen (J&J) Vaginal haemorrhage 4.3 4
2025Q3 Pfizer Bivalent Tendon disorder 4.1 4
2025Q3 Janssen (J&J) Infertility female 4.1 2
2025Q3 Moderna Vaccination site pain 4.0 4
2025Q3 Moderna Myalgia 3.9 4
2025Q3 Pfizer Bivalent Blood iron 3.7 4
2025Q3 Pfizer Bivalent Transferrin saturation 3.7 2
2025Q3 Janssen (J&J) Carpal tunnel syndrome 3.7 4
2025Q3 Moderna Histamine level 3.6 4
2025Q3 Janssen (J&J) Tilt table test positive 3.6 2
2025Q3 Pfizer Bivalent Chronic fatigue syndrome 3.5 4
2025Q3 Pfizer Bivalent Parvovirus B19 test 3.4 2
2025Q3 Pfizer Bivalent Iron binding capacity total 3.4 2
2025Q3 Moderna Headache 3.1 4
2025Q3 Pfizer Bivalent Polyneuropathy 3.1 4
2025Q4 Moderna Product closure removal difficult 24.9 3
2025Q4 Moderna Device issue 6.1 4
2025Q4 Moderna Embolism 5.8 4
2025Q4 Pfizer Bivalent Cystoscopy 4.5 2
2025Q4 Janssen (J&J) Ventricular fibrillation 4.5 2
2025Q4 Pfizer Bivalent Vasculitis 4.1 4
2025Q4 Moderna Bivalent Refusal of vaccination 4.0 4
2025Q4 Pfizer Bivalent Heart rate abnormal 3.8 4
2025Q4 Unknown Joint injury 3.4 4
2025Q4 Janssen (J&J) Thyroid disorder 3.3 2
2026Q1 Unknown Joint injection 7.5 4
2026Q1 Unknown Enzyme level test 5.8 2
2026Q1 Moderna Intercepted product administration error 5.3 4
2026Q1 Moderna Device colour issue 4.7 2
2026Q1 Moderna Device difficult to use 4.7 2
2026Q1 Moderna Device mechanical issue 3.3 2
2026Q1 Unknown Glycosylated haemoglobin increased 3.1 4
2026Q1 Moderna Injection site indentation 3.1 2
2026Q1 Moderna Mechanical urticaria 3.1 4
2021
2021Q1 Unknown Subarachnoid haemorrhage 5.4 4
2021Q1 Pfizer-BioNTech Investigation 4.9 4
2021Q1 Pfizer-BioNTech Drug ineffective 4.9 4
2021Q1 Pfizer-BioNTech COVID-19 pneumonia 4.8 4
2021Q1 Moderna Interchange of vaccine products 4.7 4
2021Q1 Unknown Dysphonia 4.6 4
2021Q1 Moderna Product temperature excursion issue 4.6 4
2021Q1 Pfizer-BioNTech Disease recurrence 4.3 4
2021Q1 Pfizer-BioNTech Blood urea 4.2 4
2021Q1 Unknown Oxygen saturation decreased 4.2 4
2021Q1 Janssen (J&J) Angiogram cerebral abnormal 4.1 4
2021Q1 Pfizer-BioNTech Body height 4.0 4
2021Q1 Pfizer-BioNTech Haematocrit 4.0 4
2021Q1 Pfizer-BioNTech Aspartate aminotransferase 4.0 4
2021Q1 Pfizer-BioNTech Alanine aminotransferase 4.0 4
2021Q1 Pfizer-BioNTech Menstrual disorder 3.9 4
2021Q1 Pfizer-BioNTech Blood creatinine 3.9 4
2021Q1 Pfizer-BioNTech Auscultation 3.8 4
2021Q1 Moderna Accidental underdose 3.8 4
2021Q1 Janssen (J&J) Vital signs measurement 3.7 4
2021Q1 Pfizer-BioNTech White blood cell count 3.7 4
2021Q1 Moderna Poor quality product administered 3.7 4
2021Q1 Unknown Autopsy 3.6 4
2021Q1 Pfizer-BioNTech Body mass index 3.6 4
2021Q1 Janssen (J&J) Product dispensing issue 3.4 4
2021Q1 Pfizer-BioNTech Suspected COVID-19 3.4 4
2021Q1 Moderna Product label confusion 3.3 4
2021Q1 Pfizer-BioNTech C-reactive protein 3.3 4
2021Q1 Pfizer-BioNTech Histology 3.3 4
2021Q1 Pfizer-BioNTech Physical examination 3.2 4
2021Q1 Pfizer-BioNTech Low density lipoprotein 3.2 4
2021Q1 Moderna Accidental overdose 3.1 4
2021Q1 Pfizer-BioNTech Antibody test 3.1 4
2021Q1 Pfizer-BioNTech PO2 3.1 4
2021Q1 Pfizer-BioNTech Blood lactate dehydrogenase 3.0 4
2021Q1 Pfizer-BioNTech Gamma-glutamyltransferase 3.0 4
2021Q1 Pfizer-BioNTech Neurological examination 3.0 4
2021Q1 Pfizer-BioNTech Pain assessment 3.0 4
2021Q1 Pfizer-BioNTech Platelet count 3.0 4
2021Q2 Janssen (J&J) Adverse event 55.4 4
2021Q2 Unknown Encephalopathy 19.3 4
2021Q2 Janssen (J&J) Therapy non-responder 13.5 4
2021Q2 Janssen (J&J) Anticoagulant therapy 11.3 4
2021Q2 Janssen (J&J) Adverse drug reaction 9.2 4
2021Q2 Janssen (J&J) Nonspecific reaction 8.3 4
2021Q2 Janssen (J&J) Heparin-induced thrombocytopenia test 7.1 4
2021Q2 Janssen (J&J) Heparin-induced thrombocytopenia test positive 6.9 4
2021Q2 Unknown Dyspnoea exertional 6.3 4
2021Q2 Janssen (J&J) Intracranial aneurysm 6.0 3
2021Q2 Janssen (J&J) Venogram normal 5.6 4
2021Q2 Janssen (J&J) Laboratory test 5.2 4
2021Q2 Janssen (J&J) Thrombectomy 5.1 4
2021Q2 Janssen (J&J) Thrombosis 4.8 4
2021Q2 Unknown Iron binding capacity total normal 4.6 2
2021Q2 Janssen (J&J) On and off phenomenon 4.6 4
2021Q2 Unknown Fibrin D dimer normal 4.4 4
2021Q2 Janssen (J&J) Cerebral thrombosis 4.4 4
2021Q2 Janssen (J&J) Coronary artery occlusion 4.2 4
2021Q2 Janssen (J&J) Intentional product misuse 4.0 4
2021Q2 Janssen (J&J) Magnetic resonance imaging 4.0 4
2021Q2 Janssen (J&J) Venogram abnormal 4.0 4
2021Q2 Janssen (J&J) Continuous haemodiafiltration 4.0 4
2021Q2 Janssen (J&J) Cerebral mass effect 3.6 4
2021Q2 Janssen (J&J) Application site pain 3.6 4
2021Q2 Janssen (J&J) Peripheral vein thrombus extension 3.5 4
2021Q2 Unknown Therapy non-responder 3.5 4
2021Q2 Moderna Product dose omission issue 3.5 4
2021Q2 Janssen (J&J) Venous occlusion 3.4 4
2021Q2 Janssen (J&J) Hidradenitis 3.3 3
2021Q2 Pfizer-BioNTech Postmenopausal haemorrhage 3.3 4
2021Q2 Janssen (J&J) Hospitalisation 3.3 4
2021Q2 Unknown Serum ferritin normal 3.3 4
2021Q2 Janssen (J&J) Poor quality product administered 3.3 4
2021Q2 Janssen (J&J) Adverse reaction 3.2 4
2021Q2 Janssen (J&J) Transverse sinus thrombosis 3.2 4
2021Q2 Janssen (J&J) Vasopressive therapy 3.1 4
2021Q2 Janssen (J&J) Computerised tomogram abdomen abnormal 3.1 4
2021Q2 Pfizer-BioNTech Myocarditis 3.1 4
2021Q2 Janssen (J&J) Ultrasound Doppler abnormal 3.1 4
2021Q2 Pfizer-BioNTech Specialist consultation 3.1 4
2021Q2 Pfizer-BioNTech Endoscopy upper gastrointestinal tract 3.1 4
2021Q2 Pfizer-BioNTech X-ray 3.1 4
2021Q2 Janssen (J&J) Application site discolouration 3.1 4
2021Q2 Janssen (J&J) Product container issue 3.0 4
2021Q2 Janssen (J&J) Ehlers-Danlos syndrome 3.0 4
2021Q2 Pfizer-BioNTech Blood phosphorus 3.0 4
2021Q2 Janssen (J&J) Ultrasound Doppler normal 3.0 4
2021Q2 Unknown End stage renal disease 3.0 2
2021Q2 Janssen (J&J) Deep vein thrombosis 3.0 4
2021Q2 Janssen (J&J) Spider vein 3.0 4
2021Q3 Janssen (J&J) Thrombosis with thrombocytopenia syndrome 18.4 4
2021Q3 Janssen (J&J) Therapy partial responder 12.7 4
2021Q3 Moderna COVID-19 immunisation 9.2 4
2021Q3 Moderna Product administration interrupted 5.5 4
2021Q3 Janssen (J&J) Vaccination failure 5.0 4
2021Q3 Janssen (J&J) Puncture site pain 4.8 4
2021Q3 Janssen (J&J) Dialysis 4.6 4
2021Q3 Janssen (J&J) Administration site pain 3.9 4
2021Q3 Unknown Reflex test normal 3.8 2
2021Q3 Janssen (J&J) COVID-19 pneumonia 3.5 4
2021Q3 Janssen (J&J) Prone position 3.3 4
2021Q3 Janssen (J&J) Renal vein thrombosis 3.3 4
2021Q3 Janssen (J&J) Impaired work ability 3.2 4
2021Q3 Janssen (J&J) Vascular catheterisation 3.1 4
2021Q3 Pfizer-BioNTech Myocardial necrosis marker 3.1 4
2021Q3 Pfizer-BioNTech Interferon gamma level 3.1 4
2021Q3 Janssen (J&J) Brain death 3.0 4
2021Q4 Unknown Poor venous access 42.7 4
2021Q4 Janssen (J&J) Neonatal dyspnoea 15.5 4
2021Q4 Unknown Exposure to vaccinated person 11.0 2
2021Q4 Janssen (J&J) Foetal exposure during pregnancy 9.4 4
2021Q4 Unknown Thrombosis with thrombocytopenia syndrome 8.6 4
2021Q4 Unknown Biliary dilatation 8.2 4
2021Q4 Janssen (J&J) Prolonged labour 7.2 4
2021Q4 Unknown Sputum discoloured 7.1 4
2021Q4 Janssen (J&J) Injury 4.6 4
2021Q4 Unknown Productive cough 4.3 4
2021Q4 Janssen (J&J) HIV infection 4.0 4
2021Q4 Unknown Crohn's disease 3.7 4
2021Q4 Unknown Haemophagocytic lymphohistiocytosis 3.7 4
2021Q4 Janssen (J&J) Septic pulmonary embolism 3.7 4
2021Q4 Moderna Mechanical urticaria 3.6 4
2021Q4 Janssen (J&J) Leg amputation 3.6 4
2021Q4 Unknown Pneumonia 3.6 4
2021Q4 Unknown Enteritis infectious 3.5 2
2021Q4 Pfizer Bivalent Blood homocysteine increased 3.4 2
2021Q4 Janssen (J&J) Death 3.3 4
2021Q4 Unknown Cardio-respiratory arrest 3.1 4
2021Q4 Janssen (J&J) Neuroendocrine tumour 3.1 3
2021Q4 Janssen (J&J) Cardiac stress test normal 3.1 2
2020
2020Q4 Pfizer-BioNTech SARS-CoV-2 test positive 4.8 4
2020Q4 Pfizer-BioNTech Respiratory rate 4.7 4
2020Q4 Pfizer-BioNTech Blood pressure measurement 4.7 4
2020Q4 Pfizer-BioNTech Pharyngeal paraesthesia 4.7 4
2020Q4 Pfizer-BioNTech Paraesthesia oral 4.6 4
2020Q4 Pfizer-BioNTech Dysgeusia 4.5 4
2020Q4 Pfizer-BioNTech Flushing 4.4 4
2020Q4 Pfizer-BioNTech Hypoaesthesia oral 4.4 4
2020Q4 Unknown Nasal congestion 4.4 4
2020Q4 Pfizer-BioNTech Exposure to SARS-CoV-2 4.4 4
2020Q4 Pfizer-BioNTech Palpitations 4.2 4
2020Q4 Unknown Dysgeusia 4.2 4
2020Q4 Pfizer-BioNTech Anosmia 4.1 4
2020Q4 Pfizer-BioNTech Sinus tachycardia 4.0 4
2020Q4 Pfizer-BioNTech SARS-CoV-2 test 4.0 4
2020Q4 Pfizer-BioNTech Throat irritation 3.9 4
2020Q4 Pfizer-BioNTech Sensation of foreign body 3.9 4
2020Q4 Pfizer-BioNTech Blood pressure increased 3.9 4
2020Q4 Pfizer-BioNTech SARS-CoV-2 antibody test 3.9 4
2020Q4 Pfizer-BioNTech Heart rate 3.9 4
2020Q4 Moderna Paraesthesia oral 3.8 4
2020Q4 Pfizer-BioNTech Body temperature 3.8 4
2020Q4 Pfizer-BioNTech Tachycardia 3.8 4
2020Q4 Pfizer-BioNTech Dry throat 3.7 4
2020Q4 Pfizer-BioNTech COVID-19 3.6 4
2020Q4 Pfizer-BioNTech Hot flush 3.6 4
2020Q4 Pfizer-BioNTech Troponin normal 3.6 4
2020Q4 Pfizer-BioNTech Throat tightness 3.6 4
2020Q4 Pfizer-BioNTech Occupational exposure to SARS-CoV-2 3.5 3
2020Q4 Pfizer-BioNTech Chest discomfort 3.5 4
2020Q4 Pfizer-BioNTech Ageusia 3.5 4
2020Q4 Unknown Pain in jaw 3.4 2
2020Q4 Pfizer-BioNTech Tongue discomfort 3.3 4
2020Q4 Pfizer-BioNTech Throat clearing 3.3 4
2020Q4 Moderna Tachycardia 3.3 4
2020Q4 Pfizer-BioNTech Oral pruritus 3.3 4
2020Q4 Pfizer-BioNTech Dry mouth 3.3 4
2020Q4 Pfizer-BioNTech Pharyngeal hypoaesthesia 3.3 4
2020Q4 Moderna SARS-CoV-2 test positive 3.2 4
2020Q4 Moderna Hypoaesthesia oral 3.2 4
2020Q4 Pfizer-BioNTech Swollen tongue 3.2 4
2020Q4 Pfizer-BioNTech Oxygen saturation normal 3.2 4
2020Q4 Pfizer-BioNTech Oropharyngeal discomfort 3.2 4
2020Q4 Moderna Flushing 3.1 4
2020Q4 Pfizer-BioNTech Heart rate increased 3.1 4
2020Q4 Pfizer-BioNTech Tongue pruritus 3.1 4
2020Q4 Pfizer-BioNTech Oxygen saturation 3.1 4
2020Q4 Pfizer-BioNTech Feeling jittery 3.1 4
2020Q4 Moderna Throat irritation 3.1 4
2020Q4 Moderna Palpitations 3.1 4

Platform Comparison

Show code 
top_events <- covid |>
  filter(n_methods_flagged >= 2) |>
  group_by(event) |>
  summarise(max_eb05 = max(eb05), .groups = "drop") |>
  arrange(desc(max_eb05)) |>
  slice_head(n = 30) |>
  pull(event)

heatmap_data <- covid |>
  filter(event %in% top_events, n_methods_flagged >= 2) |>
  select(vaccine, event, eb05) |>
  complete(vaccine, event, fill = list(eb05 = NA)) |>
  mutate(event = str_trunc(event, 48))

ggplot(heatmap_data,
       aes(vaccine, fct_reorder(event, eb05, max, na.rm = TRUE), fill = log10(eb05 + 0.01))) +
  geom_tile(colour = "white", linewidth = 0.3) +
  scale_fill_gradientn(
    colours  = c("#f7fbff", "#6baed6", "#08519c"),
    na.value = "#f0f0f0",
    name     = "log₁₀(EB05)",
    labels   = function(x) round(10^x, 1)
  ) +
  labs(
    x     = NULL,
    y     = NULL,
    title = "Top 30 Signals by EB05 — COVID-19 Vaccines"
  ) +
  theme_minimal(base_size = 11) +
  theme(
    axis.text.x  = element_text(angle = 35, hjust = 1),
    panel.grid   = element_blank()
  )

Top 30 events by maximum EB05 across all products, shown for each vaccine. Grey = not flagged at ≥2 methods.

Interpretation Summary

Domain Key finding Product(s)
Thrombosis TTS cluster — EB05 18.4, all 4 methods Janssen
Cardiac Immune-mediated myocarditis EB05 36.5; cardiac cluster in bivalent boosters mRNA (unspecified); Pfizer Bivalent
Neurological GBS, CIDP, demyelinating conditions Janssen (strongest); mRNA (lower magnitude)
Allergic Type I hypersensitivity EB05 5.0; adjuvant-related signals Moderna; Novavax
Post-COVID Post-acute COVID-19 syndrome flagged by both mRNA products Pfizer, Moderna

The Janssen product’s disproportionate representation in thrombotic and neurological signal clusters — relative to its dose volume — is the dominant cross-domain finding and is consistent with published regulatory assessments. The mRNA products share a large, lower-magnitude signal landscape dominated by reactogenicity, cardiac monitoring events, and post-COVID sequelae.

Methods

Data source: CDC VAERS (Vaccine Adverse Event Reporting System), 1990–present.

Signal detection: Four independent disproportionality methods applied to each (vaccine, adverse event) pair:

  • GPS — Gamma-Poisson Shrinker (DuMouchel 1999 framework). EB05 is the 5th-percentile lower bound of the two-component Gamma mixture posterior on the linear RR scale — a direct posterior credible bound, not the EBGM geometric mean (which uses a log transformation). EB05 > 2 is the threshold.
  • PRR — Proportional Reporting Ratio. Flagged at PRR > 2, χ² > 4, n ≥ 3.
  • ROR — Reporting Odds Ratio. Lower 95% CI > 1.
  • BCPNN/IC — Bayesian Confidence Propagation Neural Network Information Component. IC025 > 0.

Signal definition: Flagged by ≥2 of 4 methods. Primary effect-size metric: EB05.

Implementation: safetysignal R package (GPS dual-Gamma posterior); standard formulae for PRR, ROR, IC.

Analysis produced by Global Patient Safety. Data: public domain (CDC). Not medical advice.