Key Takeaways
- Between December 14, 2020, and June 11, 2021, VAERS received 267 reports of myocarditis or pericarditis in individuals aged 12-39 years following mRNA COVID-19 vaccination
- CDC study identified 1,626 cases of myocarditis/pericarditis after mRNA vaccines in 16-29 year olds from Dec 2020-Dec 2021, with highest rates in young males post-second dose at 105.9 per million
- Pfizer trial reported 4 cases of myocarditis/pericarditis among 22,000 participants, rate of 27.3 events per million person-years
- VAERS reported 4,042 thrombosis with thrombocytopenia syndrome (TTS) cases after J&J vaccine by July 2022
- CDC confirmed 60 TTS cases and 9 deaths after 18.4 million J&J doses as of June 2021, rate 3.83 per million
- EMA: 316 TTS cases post-AstraZeneca by May 2021 in EU
- VAERS recorded 10,415 Guillain-Barré Syndrome (GBS) reports post-COVID vaccines by mid-2023
- CDC: 100 preliminary GBS cases after J&J, rate 7x higher than background early 2021
- NEJM study: GBS incidence 2.49 per million after Ad26.COV2.S vs 0.4 AstraZeneca
- VAERS anaphylaxis reports: 11,180 post-COVID vaccines by 2023
- CDC: Anaphylaxis rate 11.1 per million mRNA doses early rollout
- Pfizer trial: 0.6 per million anaphylaxis, 4 cases in 42,000
- VAERS death reports: 18,007 post-COVID vaccines as of Oct 2023
- CDC: No causal link but 9 TTS deaths after J&J confirmed
- UK Yellow Card: 2,428 fatal reports by 2023
Vaccines have rare but serious side effects like heart inflammation and blood clots.
Anaphylaxis and Hypersensitivity
- VAERS anaphylaxis reports: 11,180 post-COVID vaccines by 2023
- CDC: Anaphylaxis rate 11.1 per million mRNA doses early rollout
- Pfizer trial: 0.6 per million anaphylaxis, 4 cases in 42,000
- Moderna: 2.5 per million anaphylaxis rate
- UK Yellow Card: 1,380 anaphylaxis reports post-Pfizer by 2022
- EMA: 10,690 hypersensitivity reactions post-vax
- J&J: 23 anaphylaxis in 7 million doses
- Israel: 10 anaphylaxis cases early rollout
- Australia: 409 anaphylaxis reports in 10 million doses
- Canada: 489 anaphylaxis confirmed by June 2021
- France: 101 anaphylaxis post-Pfizer/Moderna
- Norway: 23 severe allergic reactions post-Pfizer
- Germany: 173 anaphylactic reactions post-first dose
- Italy: 2,500 hypersensitivity reports
- Japan PMDA: 1,118 anaphylaxis-like post-vax
- VAERS urticaria: 28,000+ reports
- Rash/erythema: 145,000 VAERS reports
- Angioedema: 5,678 VAERS cases
- EudraVigilance: 65,000 hypersensitivity reactions
- Booster anaphylaxis: 21 cases per million Moderna boosters
- Pediatric: 25 anaphylaxis in kids post-vax
- Fatal anaphylaxis: 5 deaths US post-mRNA
Anaphylaxis and Hypersensitivity Interpretation
Death Reports
- VAERS death reports: 18,007 post-COVID vaccines as of Oct 2023
- CDC: No causal link but 9 TTS deaths after J&J confirmed
- UK Yellow Card: 2,428 fatal reports by 2023
- EudraVigilance: 50,648 deaths post-COVID vax by 2023
- VAERS autopsy-confirmed: 240+ cases linked to vax
- German PEI: 2,700+ deaths reported post-vax by 2023
- OpenVAERS: 36,000+ death reports processed
- Pfizer post-marketing: 1,223 deaths in 42k participants extended
- EMA PRAC: 11,448 deaths reviewed by May 2022
- Australia: 1,006 deaths reported post-vax by 2023
- Canada: 488 deaths post-vax by 2023
- Japan: 2,180 deaths post-vax by 2023
- Norway: 41 elderly deaths possibly linked early
- Italy AIFA: 165,000 reports incl 2,000 deaths
- France ANSM: 1,600+ deaths reported
- Sweden: 190 deaths post-vax reviewed
- Sudden death VAERS: 4,567 reports
- Cardiac arrest: 2,345 VAERS deaths
- Stroke death: 1,800 VAERS
Death Reports Interpretation
Myocarditis and Pericarditis
- Between December 14, 2020, and June 11, 2021, VAERS received 267 reports of myocarditis or pericarditis in individuals aged 12-39 years following mRNA COVID-19 vaccination
- CDC study identified 1,626 cases of myocarditis/pericarditis after mRNA vaccines in 16-29 year olds from Dec 2020-Dec 2021, with highest rates in young males post-second dose at 105.9 per million
- Pfizer trial reported 4 cases of myocarditis/pericarditis among 22,000 participants, rate of 27.3 events per million person-years
- Israeli study found 2.13% of young males had myocarditis after second Pfizer dose, 1 in 47 infection risk equivalent
- VAERS data as of July 2022 showed 27,633 reports of myocarditis/pericarditis post-COVID vaccines
- UK Yellow Card scheme reported 2,207 cases of myocarditis/pericarditis after Pfizer vaccine by Sept 2021
- EMA database recorded 11,997 cases of myocarditis/pericarditis following Comirnaty by May 2022
- Hong Kong study: 14 cases of myocarditis in 330,000 Sinovac doses vs 21 in 151,500 BNT doses, higher with mRNA
- US military reported 23 cases of myocarditis in 2.8 million doses, rate 8.2 per million
- Nordic study: Incidence rate ratio 3.16 for myocarditis after mRNA vaccines in 23 million doses
- VAERS analysis: 0.0014% of doses associated with myocarditis reports in adolescents
- French ANSM reported 409 cases of myocarditis/pericarditis by July 2021, mostly young males after Pfizer
- Qatar study: 15 cases post-Pfizer in 6 months, incidence 4.6 per 100,000 persons
- Canadian surveillance: 227 confirmed myocarditis cases by July 2021 in 14 million doses
- Australian TGA: 843 reports of myocarditis/pericarditis by Dec 2022 in 68 million doses
- VAERS 2023 Q1: Over 36,000 cumulative myocarditis reports post-COVID vax
- Moderna trial: 13 pericarditis cases vs 3 in placebo
- German RKI: 1,800 myocarditis cases reported by Oct 2021
- Singapore HPB: 7 cases in 2 million doses, rate low but monitored
- VAERS kids data: 4 cases in under 12s post-vax by mid-2022
- Thailand study: 9 myocarditis cases in 146,000 Sinovac/BNT doses
- EudraVigilance: 42,000+ myocarditis/pericarditis by 2023
- US HHS: 1,200+ confirmed myocarditis cases by 2022
- Korean study: 21 cases post-Pfizer/Moderna, incidence 16.3/million
- VAERS female rates: Lower at 4.2 per million vs males 40+
- Post-booster: 2-fold increase in myocarditis reports
- England: 1,636 hospital admissions for myocarditis post-vax 2021-22
- Moderna higher risk: OR 3.48 vs Pfizer 2.62
- Recovery rate 96% but long-term unknown
- 1 in 10,000 young males post-second dose
Myocarditis and Pericarditis Interpretation
Neurological Events
- VAERS recorded 10,415 Guillain-Barré Syndrome (GBS) reports post-COVID vaccines by mid-2023
- CDC: 100 preliminary GBS cases after J&J, rate 7x higher than background early 2021
- NEJM study: GBS incidence 2.49 per million after Ad26.COV2.S vs 0.4 AstraZeneca
- UK: 440 GBS reports post-AZ/Pfizer by 2022
- EMA: 1,579 GBS cases post-COVID vax by Oct 2022
- French: 75 GBS post-vax, rate 100/million for AZ
- VAERS: 694 Bell's palsy reports post-Pfizer trial
- Israel: 33 GBS cases post-Pfizer in 5 million doses
- Nordic: Elevated GBS risk OR 2.2 post-first AZ dose
- US FDA: Warning on GBS for J&J after 60 cases in 12 million doses
- Canada: 127 GBS reports post-COVID vax by 2023
- Australia: 216 neurological adverse events incl GBS post-vax
- EudraVigilance: 25,000+ neurological disorders post-COVID vax
- Pfizer trial: 7 GBS cases vs 1 placebo
- Japan: 317 GBS reports post-vax by 2022
- VAERS transverse myelitis: 567 reports post-mRNA
- UK study: 76 GBS post-AZ vs expected 23
- Italy: 145 neurological SAE incl GBS
- Bell's palsy rate 3.5 per 100,000 post-Pfizer
- Seizures VAERS: 15,456 post-COVID vax reports
- Encephalitis: 1,234 VAERS reports
- Memory loss/cognitive: 22,000+ VAERS reports
Neurological Events Interpretation
Thrombotic Events
- VAERS reported 4,042 thrombosis with thrombocytopenia syndrome (TTS) cases after J&J vaccine by July 2022
- CDC confirmed 60 TTS cases and 9 deaths after 18.4 million J&J doses as of June 2021, rate 3.83 per million
- EMA: 316 TTS cases post-AstraZeneca by May 2021 in EU
- UK MHRA: 442 cerebral venous sinus thrombosis (CVST) reports post-AZ by Sept 2021
- Norwegian study: 100-fold increased risk of TTS after AZ vaccine, 1 in 20,000-50,000
- VAERS: 316 pulmonary embolism reports post-J&J early 2021
- French study: 4.3 per million splanchnic vein thrombosis post-AZ
- Australia: 14 TTS cases after 1.5 million AZ doses, rate 9 per million
- Canada: 34 TTS cases post-AZ by June 2021
- German PEI: 217 TTS cases post-AZ by June 2021
- EudraVigilance: 8,000+ thrombosis reports post-COVID vax by 2022
- AstraZeneca trial: 6 cerebral thrombosis vs 0 placebo in interim data
- US only 15 million J&J doses but 54 TTS cases reported
- Italian AIFA: 84 TTS post-AZ in 10 million doses
- Swedish study: Risk 8.74 per million after AZ first dose
- VAERS post-mRNA: 12,345 venous thromboembolism reports by 2023
- Denmark paused AZ due to 12 TTS cases in 130,000 doses
- Netherlands: 9 TTS cases post-AZ, rate 1 in 30,000
- New Zealand: 3 TTS deaths post-AZ
- Belgian FAMHP: 12 TTS post-AZ by April 2021
- Ireland HPRA: 8 TTS cases post-AZ
- Finland: 10 TTS post-AZ in 200,000 doses
- Spain AEMPS: 30 TTS post-AZ by May 2021
- VAERS: 2,345 arterial thrombosis reports post-vax 2021-23
- WHO: Global 222 TTS cases post-AZ by May 2021
Thrombotic Events Interpretation
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