Recently released pharmacovigilance documents by the European Medicines Agency (EMA) indicate that Pfizer was aware of substantial adverse side effects related to its COVID-19 vaccine as early as August 2022.
The documents reveal a total of 1,597,673 adverse events, one-third of which were classified as serious. A staggering 60% of cases were reported as “outcome unknown” or “not recovered,” suggesting a prevalence of non-transient injuries.
Notably, Pfizer reported over 10,000 categories of diagnosis from the vaccine, many of them severe and rare. A breakdown of some of these includes:
- 73,542 cases of 264 categories of vascular disorders
- 696,508 cases of numerous categories of nervous system disorders
- Over 61,518 cases of more than 100 categories of eye disorders
- Over 47,000 ear disorders, including almost 16,000 cases of tinnitus
- Approximately 225,000 cases of skin and tissue disorders
- Roughly 190,000 cases of respiratory disorders
- Over 178,000 cases of reproductive or breast disorders
- Over 77,000 psychiatric disorders
- 3,711 cases of benign and malignant tumors
- Almost 127,000 cardiac disorders
- Over 100,000 blood and lymphatic disorders
The documents indicate that Pfizer was aware of these adverse events, many of which were identified in independent studies, raising questions about why more hasn’t been done to address these safety concerns.
The FDA has not updated its labeling to reflect these side effects as requested by Peter Doshi, editor of the British Medical Journal, despite the fact that their causal relationship to the vaccine is backed by extensive research.
Unfortunately, the FDA denied the causal relationship between these side effects and the COVID-19 vaccine, while the current label continues to affirm the shot’s safety and effectiveness. The question now is whether Republicans in the House will leverage appropriations bills to compel the FDA to comply with the law.