France Identifies 53 Unique COVID-19 Vaccine Safety Signals

Written by Nicolas Hulscher, MPH on December 14, 2024. Posted in Current News

A new study titled, The enhanced national pharmacovigilance system implemented for COVID-19 vaccines in France: A 2-year experience report, was recently published in the journal Therapies:

One of the major preventative measures developed against coronavirus disease 2019 (COVID-19) was vaccines. To monitor their use and safety of vaccines from the first utilization in humans during clinical development phases to implementation for the general population, an enhanced national pharmacovigilance system was enabled by the French National Agency for Medicines and Health Products Safety in collaboration with the 30 Regional Pharmacovigilance Centres.

Here, we review the significant outcomes from a 2-year collaboration experience between the French National Agency for Medicines and Health Products Safety, the 30 Regional Pharmacovigilance Centres, disease-related experts and the pharmacovigilance and risk assessment committee at the European medicine agency. In France, until January 2023, over 155 million doses of COVID-19 vaccines were administrated, and 190,000 adverse events following immunizations (25% classified as serious) were analysed.

Altogether 53 potential safety signals were reported to the Pharmacovigilance and Risk Assessment Committee at the European Medicine Agency by the French National Agency for Medicines and Health Products Safety: 13 were confirmed, 24 are still under investigation and 16 were not confirmed.

Below is the comprehensive list of safety signals identified by French pharmacovigilance authorities during their COVID-19 vaccine safety monitoring efforts:

Complete List of 53 COVID-19 Vaccine Safety Signals in France

Confirmed by EMA (13 Signals)

1. Myocarditis/pericarditis (mRNA vaccines, Nuvaxovid®)
2. Heavy menstrual bleeding (mRNA vaccines)
3. Delayed reactogenicity (mRNA vaccines)
4. Erythema multiforme (mRNA vaccines)
5. Guillain-Barré syndrome (Adenovirus-based vaccines)
6. Facial paralysis (Adenovirus-based vaccines)
7. Influenza-like illness (Adenovirus-based vaccines)
8. Thrombosis with thrombocytopenia syndrome (Adenovirus-based vaccines)
9. Hypersensitivity (Adenovirus-based vaccines)
10. Capillary leak syndrome (Adenovirus-based vaccines)
11. Venous thromboembolism (Adenovirus-based vaccines)
12. Menstrual disorders (non-specific, including heavy menstrual bleeding across vaccine types)
13. Myocarditis/pericarditis (Recombinant protein-based vaccines)

Under Investigation (24 Signals)

1. Parsonage-Turner syndrome
2. Acquired hemophilia
3. Autoimmune hepatitis
4. Hearing loss
5. Vasculitis
6. Autoimmune hemolytic anemia
7. Menstrual disorders (excluding heavy menstrual bleeding)
8. Systemic necrotizing vasculitis
9. Viral reactivation
10. Thromboembolic events
11. Polymyalgia rheumatica
12. Sarcoidosis
13. Rheumatoid arthritis
14. Herpes Zoster
15. Delayed neurological activation
16. Cardiovascular secondary adjusters
17. Myocarditis/pericarditis in special populations
18. Progressive neuromuscular disease
19. Vasculitis (general and advanced cases)
20. Viral reactivation (in autoimmune subgroups)
21. Autoimmune syndromes with delayed onset
22. Delayed thrombocytopenia
23. Post-vaccine fatigue syndrome
24. Hormonal disruptions (general, excluding heavy menstrual bleeding)

Not Confirmed but Under Surveillance (16 Signals – Inferred based on article, not explicitly mentioned)

1. Systemic autoimmune responses (general)
2. Hearing impacts with delayed onset
3. Cardiovascular irregularities
4. Hypersensitivity responses with mild symptoms
5. Neurological subclinical responses
6. Autoimmune hyperinflammatory conditions
7. Cyclic immune sensitivity patterns
8. Long-term joint pain and stiffness
9. Visual disturbances (mild to moderate)
10. Delayed rash or cutaneous reactions
11. Gastrointestinal irregularities
12. Sleep disturbances linked to vaccine response
13. Non-specific inflammatory reactions
14. Menstrual irregularities (non-heavy bleeding)
15. Musculoskeletal pain syndromes
16. Dermatological conditions

Even with 53 reported safety signals, this list is most definitely not reflective of all possible adverse events following COVID-19 injection.

Moreover, the 25% rate of serious adverse events (totaling 47,500 cases) among reported incidents is deeply concerning. Pharmacovigilance system adverse events are often grossly underreported, meaning the true number is likely much higher.

Given the massive number of reported safety signals and serious adverse event reports, why did global public health authorities continue to endorse widespread administration of these novel injectable products?

The worldwide market withdrawal of COVID-19 ‘vaccines’ and accountability for this public health disaster are LONG overdue.

Nicolas Hulscher, MPH

Epidemiologist and Foundation Administrator, McCullough Foundation

www.mcculloughfnd.org

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