A French study evaluated a pharmacovigilance system for COVID-19 vaccines over two years, analyzing over 155 million doses and 190,000 adverse events (25% serious). It identified 53 safety signals: 13 confirmed, 24 under investigation, and 16 not confirmed. Key signals include myocarditis, heavy menstrual bleeding, and various autoimmune conditions. The reported serious adverse event rate raises concerns about the vaccines, leading to questions on public health authorities' continued endorsement despite potential underreporting and the high number of safety signals.
France Identifies 53 COVID-19 Vaccine Safety Signals New study reports 190,000 adverse events following COVID-19 vaccination in France, with 25% classified as serious. Fri, 06 Dec 2024 23:44:27 GMT https://petermcculloughmd.substack.com/p/france-identifies-53-covid-19-vaccine by Nicolas Hulscher, MPH
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 Safety Signals in France Confirmed by EMA (13 Signals) Myocarditis/pericarditis (mRNA vaccines, Nuvaxovid®)
Heavy menstrual bleeding (mRNA vaccines)
Delayed reactogenicity (mRNA vaccines)
Erythema multiforme (mRNA vaccines)
Guillain-Barré syndrome (Adenovirus-based vaccines)
Facial paralysis (Adenovirus-based vaccines)
Influenza-like illness (Adenovirus-based vaccines)
Thrombosis with thrombocytopenia syndrome (Adenovirus-based vaccines)
Hypersensitivity (Adenovirus-based vaccines)
Capillary leak syndrome (Adenovirus-based vaccines)
Venous thromboembolism (Adenovirus-based vaccines)
Menstrual disorders (non-specific, including heavy menstrual bleeding across vaccine types)
Myocarditis/pericarditis (Recombinant protein-based vaccines)
Under Investigation (24 Signals) Parsonage-Turner syndrome
Acquired hemophilia
Autoimmune hepatitis
Hearing loss
Vasculitis
Autoimmune hemolytic anemia
Menstrual disorders (excluding heavy menstrual bleeding)
Systemic necrotizing vasculitis
Viral reactivation
Thromboembolic events
Polymyalgia rheumatica
Sarcoidosis
Rheumatoid arthritis
Herpes Zoster
Delayed neurological activation
Cardiovascular secondary adjusters
Myocarditis/pericarditis in special populations
Progressive neuromuscular disease
Vasculitis (general and advanced cases)
Viral reactivation (in autoimmune subgroups)
Autoimmune syndromes with delayed onset
Delayed thrombocytopenia
Post-vaccine fatigue syndrome
Hormonal disruptions (general, excluding heavy menstrual bleeding)
Not Confirmed but Under Surveillance (16 Signals - Inferred based on article, not explicitly mentioned) Systemic autoimmune responses (general)
Hearing impacts with delayed onset
Cardiovascular irregularities
Hypersensitivity responses with mild symptoms
Neurological subclinical responses
Autoimmune hyperinflammatory conditions
Cyclic immune sensitivity patterns
Long-term joint pain and stiffness
Visual disturbances (mild to moderate)
Delayed rash or cutaneous reactions
Gastrointestinal irregularities
Sleep disturbances linked to vaccine response
Non-specific inflammatory reactions
Menstrual irregularities (non-heavy bleeding)
Musculoskeletal pain syndromes
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 42,500 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
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