Washington, DC, March 03, 2022 (GLOBE NEWSWIRE) -- In a 55,000-page set of documents released on Tuesday, the U.S. Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER) is for the first time allowing the public to access data Pfizer submitted to FDA from its clinical trials in support of a COVID-19 vaccine license. This follows U.S. District Judge Mark T. Pittman’s decision on January 6 to deny the request from the FDA to suppress the data for the next 75 years which the agency claimed was necessary, in part, because of its “limited resources.” 

A 38-page report included in the documents features an Appendix, “LIST OF ADVERSE EVENTS OF SPECIAL INTEREST,” that lists 1,291 different adverse events following vaccination. The list includes acute kidney injury, acute flaccid myelitis, anti-sperm antibody positive, brain stem embolism, brain stem thrombosis, cardiac arrest, cardiac failure, cardiac ventricular thrombosis, cardiogenic shock, central nervous system vasculitis, death neonatal, deep vein thrombosis, encephalitis brain stem, encephalitis hemorrhagic, frontal lobe epilepsy, foaming at mouth, epileptic psychosis, facial paralysis, fetal distress syndrome, gastrointestinal amyloidosis, generalized tonic-clonic seizure, Hashimoto's encephalopathy, hepatic vascular thrombosis, herpes zoster reactivation, immune-mediated hepatitis, interstitial lung disease, jugular vein embolism, juvenile myoclonic epilepsy, liver injury, low birth weight, multisystem inflammatory syndrome in children, myocarditis, neonatal seizure, pancreatitis, pneumonia, stillbirth, tachycardia, temporal lobe epilepsy, testicular autoimmunity, thrombotic cerebral infarction, Type 1 diabetes mellitus, venous thrombosis neonatal, and vertebral artery thrombosis among 1,246 other medical conditions following vaccination.

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5.3.6-pfizer-postmarketing-experience.pdf