As of March 2022, Pfizer has finally released their COVID-19 Vaccine Post Marketing Experience papers. These documents are a result of the cumulative cases reports up until February, 2021. All adverse events and potential risks were recorded in depth out of 42,086 subjects, diverse in age, sex, and race. Some of the major adverse event categories that resulted in serious and life threatening effects are; vaccine associated enhanced disease, vaccine enhanced respiratory disease, effects in pregnancy & lactation, pyrexia (fevers), cerebrovascular venous & sinus thrombosis, facial paralysis, immune-mediated effects, musculoskeletal effects, anaphylactic reactions, cardiovascular effects, and lack of efficacy. This does not include the last 8 pages of the document that lists every known adverse event of special interest. Click here to read the Pfizer Post Marketing Experience.
Looking into lack of efficacy, out of 42,086 people, 1665 (3.9%) of the total PM database reported lack of efficacy events. 1646 reported drug ineffectiveness and 19 vaccine failures. Drug ineffective event seriousness: serious (1625), non-serious (21). Lack of efficacy term was reported: after the 1st dose in 788 cases, after the 2nd dose in 139 cases.
For cardiovascular adverse events, 1403 cases (3.3% of the total PM dataset) were confirmed. 1441 relevant events occurred with 946 serious adverse events and 496 non-serious. Reported serious adverse events include, but are not limited to, Tachycardia (1098), Arrhythmia (102), Myocardial infarction (41), Cardiac failure (80), Acute myocardial infarction (41), and cardiac failure acute (11). It’s crazy to now see that myocarditis and pericarditis are one of many cardiovascular side effects of the mRNA vaccine.
One adverse effect in particular that makes up a marginal percent of total effects is musculoskeletal effects. 3600 (8.5% of the total PM dataset), of which 2045 medically confirmed and 1555 non-medically confirmed. Subjects were male (3471 and female (2760) with adults (2850), elderly (515) child (4) and infant (1). There were a total of 1614 serious cases and 2026 non-serious cases. Reported effects are; Arthralgia (3525), Arthritis (70), Rheumatoid Arthritis (26), Polyarthritis (5), Polyneuropathy, Post viral fatigue syndrome, Chronic fatigue syndrome (4 each).
The most frequently reported relevant events make up 8241 cases (19.6%), of which 3674 serious and 4568 non-serious. These events include, but are not limited to, Pyrexia (7666), Herpes Zoster (259), Inflammation (132), Oral Herpes (80), Multiple organ dysfunction syndrome (18), Herpes virus infection (17), Herpes simplex (13), and Ophthalmic herpes zoster (10).
Moving onto an adverse effect that some may have heard is facial paralysis. Facial paralysis is a loss of facial movement due to nerve damage. Your facial muscles may appear to droop or become weak. Common causes of facial paralysis include: infection or inflammation of the facial nerve. Number of cases are 449 (1.07% of the total PM database), of which 314 medically confirmed and 135 non-medically confirmed. 399 out of the 453 reported events were deemed serious and 54 non serious.
In the cerebrovascular venous and sinus thrombosis category, 300 events occurred that were all serious. Cerebrovascular venous occurs when a blood clot forms in the brain’s venous sinuses. This prevents blood from draining out of the brain. As a result, blood cells may break and leak blood into the brain tissues, forming hemorrhage. Most frequently reported relevant events included: Ischemic stroke (41), Cerebrovascular accident (160), Cerebral infarction (15), Cerebral hemorrhage (26), and Hemorrhagic stroke (11). Relevant outcomes include fatal (61), resolved with sequelae (10), not resolved (85) and unknown (83). Pfizer continued to conclude with the statement that this cumulative case review does not raise new safety issues and that surveillance will continue.
Although there are only 6 adverse events listed above, within the documents that Pfizer released, we can see thousands of more significant side effects. To be exact, 8 pages full of adverse effects from the mRNA COVID-19 vaccine. Once you read the documents, take a look at the bottom of the page of each adverse event. The conclusion to each one is: “This cumulative case review does not raise new safety issues. Surveillance will continue”. What other extreme, life threatening events need to occur for Pfizer to raise concern on their vaccine? From brain hemorrhage to facial paralysis and musculoskeletal events - isn’t this enough? How many lives are now at future risk of these adverse events compared to COVID-19. What’s the real killer here? Lots of questions and now serious adverse events that have come forward due to the release of Pfizer’s marketing event. It’s important to understand the potential effects that can happen with putting vaccines into your body. Know the effects and take everything with a grain of salt.