Pfizer has starting releasing their vaccine safety data per a court-ordered instruction to satisfy a freedom of information request. The data for the first 3 months has been released and partially analyzed. Pfizer reports over 47000 adverse effects and 127 deaths in the first 3 months. This is roughly in line with Vaccine Adverse Event Reporting System (VAERS). There Moderna and Pfizer vaccines being administered.
On February 19, 2021, this report was posted online as an MMWR Early Release.
During December 14, 2020–January 13, 2021, a total of 13,794,904 COVID-19 vaccine doses were administered in the United States; 8,436,863 (61.2%) doses were administered to women. VAERS received 6,994 reports of COVID-19–associated adverse events during this period. Among all reports, 6,354 (90.8%) were classified as nonserious and 640 (9.2%) as serious, including 113 (1.6%) deaths.
Safety monitoring for these vaccines has been the most intense and comprehensive in U.S. history, using the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system, and v-safe,* an active surveillance system, during the initial implementation phases of the COVID-19 national vaccination program.
The occurrence of anaphylaxis after receipt of COVID-19 vaccines during the analytic period, 4.5 cases per million doses administered, is within the range reported after receipt of inactivated influenza vaccine (1.4 per million), pneumococcal polysaccharide vaccine (2.5 per million), and live attenuated herpes zoster vaccine (9.6 per million); effective treatments for anaphylaxis exist.
VAERS received 113 reports of death after COVID-19 vaccinations; two thirds of these deaths occurred among LTCF residents. All-cause mortality is high in LTCF populations because underlying medical conditions are common. Based on expected rates of background mortality, among the approximately 1 million LTCF residents vaccinated in the first month of the U.S. COVID-19 vaccination program, approximately 7,000 coincidental, temporally associated deaths from all causes would be expected during the analytic period. In contrast, VAERS received 78 reports of death after COVID-19 vaccination in LTCF residents, and approximately one-half were in residents who were in hospice or who had a do-not-resuscitate status. Reported causes of death in LTCF residents after COVID-19 vaccination are consistent with expected all-cause mortality in this population.
Vaccine adverse events include:
Acute kidney injury
Acute flaccid myelitis
Anti-sperm antibody positive
Brain stem embolism
Brain stem thrombosis
Cardiac ventricular thrombosis
Central nervous system vasculitis
Deep vein thrombosis
Encephalitis brain stem
VAERS and v-safe during Dec 14, 2020, to June 14, 2021. VAERS reports were categorised as non-serious, serious, or death. Reporting rates were calculated using numbers of COVID-19 doses administered as the denominator. We analysed v-safe survey reports from days 0–7 after vaccination for reactogenicity, severity (mild, moderate, or severe), and health impacts (ie, unable to perform normal daily activities, unable to work, or received care from a medical professional).
6 Months Findings
During the study period, 298 792 852 doses of mRNA vaccines were administered in the USA.
VAERS processed 340 522 reports:
313 499 (92·1%) were non-serious,
22 527 (6·6%) were serious (non-death), and
4496 (1·3%) were deaths.
Over half of 7 914 583 v-safe participants self-reported local and systemic reactogenicity, more frequently after dose two (4 068 447 [71·7%] of 5 674 420 participants for local reactogenicity and 4 018 920 [70·8%] for systemic) than after dose one (4 644 989 [68·6%] of 6 775 515 participants for local reactogenicity and 3 573 429 [52·7%] for systemic). Injection-site pain (4 488 402 [66·2%] of 6 775 515 participants after dose one and 3 890 848 [68·6%] of 5 674 420 participants after dose two), fatigue (2 295 205 [33·9%] participants after dose one and 3 158 299 participants [55·7%] after dose two), and headache (1 831 471 [27·0%] participants after dose one and 2 623 721 [46·2%] participants after dose two) were commonly reported during days 0–7 following vaccination. Reactogenicity was reported most frequently the day after vaccination; most reactions were mild. More reports of being unable to work, do normal activities, or of seeking medical care occurred after dose two (1 821 421 [32·1%]) than after dose one (808 963 [11·9%]); less than 1% of participants reported seeking medical care after vaccination (56 647 [0·8%] after dose one and 53 077 [0·9%] after dose two).
SOURCES- CDC, Dr John Campbell, Pfizer, VAERS
Written by Brian Wang, Nextbigfuture.com
Brian Wang is a Futurist Thought Leader and a popular Science blogger with 1 million readers per month. His blog Nextbigfuture.com is ranked #1 Science News Blog. It covers many disruptive technology and trends including Space, Robotics, Artificial Intelligence, Medicine, Anti-aging Biotechnology, and Nanotechnology.
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