@NobodyzFoolz
9h
@PoliticalMadness
"Yes Satanist Do LOVE Their Symbols!!!"
Posted on 03/08/2021 3:27:46 PM PST by ransomnote
@NobodyzFoolz
9h
@PoliticalMadness
"Yes Satanist Do LOVE Their Symbols!!!"
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.
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Lol - mark for reading later...
Because it’s so long, I post the transcript out in the sticks and post the link to the thread now on the forum. I forget people can even see things out here because I don’t watch ‘comments’ in the forum, I monitor articles.
Another example is the test for covid and many medical interments. For covid hey use a swab sanitized with Ethylene Oxide which is gives a very high chance of cancer according to the CDC. If I ever have to go too the doctor I'm going to tell them I'm allergic to Ethylene.
https://www.cdc.gov/infectioncontrol/guidelines/disinfection/sterilization/ethylene-oxide.html
VAERS Table of Reportable Events Following Vaccination* Vaccine/Toxoid Event and interval** from vaccination Tetanus in any combination; DTaP, DTP, DTP-Hib, DT, Td, TT, Tdap, DTaP-IPV, DTaP-IPV/Hib, DTaP-HepB-IPV A. Anaphylaxis or anaphylactic shock (7 days)
B. Brachial neuritis (28 days)
C. Shoulder Injury Related to Vaccine Administration (7 days)
D. Vasovagal syncope (7 days)
E. Any acute complications or sequelae (including death) of above events (interval - not applicable)
F. Events described in manufacturer’s package insert as contraindications to additional doses of vaccine (interval - see package insert)Pertussis in any combination; DTaP, DTP, DTP- Hib, Tdap, DTaP-IPV, DTaP-IPV/Hib, DTaP-HepB- IPV A. Anaphylaxis or anaphylactic shock (7 days)
B. Encephalopathy or encephalitis (7 days)
C. Shoulder Injury Related to Vaccine Administration (7 days)
D. Vasovagal syncope (7 days)
E. Any acute complications or sequelae (including death) of above events (interval - not applicable)
F. Events described in manufacturer’s package insert as contraindications to additional doses of vaccine (interval - see package insert)Measles, mumps and rubella in any combination; MMR, MMRV, MM A. Anaphylaxis or anaphylactic shock (7 days)
B. Encephalopathy or encephalitis (15 days)
C. Shoulder Injury Related to Vaccine Administration (7 days)
D. Vasovagal syncope (7 days)
E. Any acute complications or sequelae (including death) of above events (interval - not applicable)
F. Events described in manufacturer’s package insert as contraindications to additional doses of vaccine (interval - see package insert)Rubella in any combination; MMR, MMRV A. Chronic arthritis (42 days)
B. Any acute complications or sequelae (including death) of above event (interval - not applicable)
C. Events described in manufacturer’s package insert as contraindications to additional doses of vaccine (interval - see package insert)Measles in any combination; MMR, MMRV, MM A. Thrombocytopenic purpura (7-30 days)
B. Vaccine-strain measles viral infection in an immunodeficient recipient
o Vaccine-strain virus identified (interval - not applicable)
o If strain determination is not done or if laboratory testing is inconclusive (12 months)
C. Any acute complications or sequelae (includingVaccine/Toxoid Event and interval** from vaccination death) of above events (interval - not applicable)
D. Events described in manufacturer’s package insert as contraindications to additional doses of vaccine (interval - see package insert)Oral Polio (OPV) A. Paralytic polio
o in a non-immunodeficient recipient (30 days)
o in an immunodeficient recipient (6 months)
o in a vaccine-associated community case (interval - not applicable)
B. Vaccine-strain polio viral infection
o in a non-immunodeficient recipient (30 days)
o in an immunodeficient recipient (6 months)
o in a vaccine-associated community case (interval - not applicable)
C. Any acute complication or sequelae (including death) of above events (interval - not applicable)
D. Events described in manufacturer’s package insert as contraindications to additional doses of vaccine (interval - see package insert)Inactivated Polio in any combination-IPV, DTaP- IPV, DTaP-IPV/Hib, DTaP-HepB-IPV A. Anaphylaxis or anaphylactic shock (7 days)
B. Shoulder Injury Related to Vaccine Administration (7 days)
C. Vasovagal syncope (7 days)
D. Any acute complication or sequelae (including death) of the above event (interval - not applicable)
E. Events described in manufacturer’s package insert as contraindications to additional doses of vaccine (interval - see package insert)Hepatitis B in any combination- HepB, HepA-HepB, DTaP-HepB-IPV, Hib-HepB A. Anaphylaxis or anaphylactic shock (7 days)
B. Shoulder Injury Related to Vaccine Administration (7 days)
C. Vasovagal syncope (7 days)
D. Any acute complications or sequelae (including death) of the above event (interval - not applicable)
E. Events described in manufacturer’s package insert as contraindications to additional doses of vaccine (interval - see package insert)Haemophilus influenzae type b in any combination (conjugate)- Hib, Hib-HepB, DTaP-IPV/Hib, Hib- MenCY A. Shoulder Injury Related to Vaccine Administration (7 days)
B. Vasovagal syncope (7 days)
C. Any acute complication or sequelae (including death) of above events (interval - not applicable)
D. Events described in manufacturer’s package insert as contraindications to additional doses of vaccineVaccine/Toxoid Event and interval** from vaccination (interval - see package insert) Varicella in any combination- VAR, MMRV A. Anaphylaxis or anaphylactic shock (7 days)
B. Disseminated varicella vaccine-strain viral disease.
o Vaccine-strain virus identified (time interval unlimited)
o If strain determination is not done or if laboratory testing is inconclusive (42 days)
C. Varicella vaccine-strain viral reactivation (time interval unlimited )
D. Shoulder Injury Related to Vaccine Administration (7 days)
E. Vasovagal syncope (7 days)
F. Any acute complication or sequelae (including death) of above events (interval - not applicable)
G. Events described in manufacturer’s package insert as contraindications to additional doses of vaccine (interval - see package insert)Rotavirus (monovalent or pentavalent) RV1, RV5 A. Intussusception (21 days)
B. Any acute complication or sequelae (including death) of above events (interval - not applicable)
C. Events described in manufacturer’s package insert as contraindications to additional doses of vaccine (interval - see package insert)Pneumococcal conjugate(7-valent or 13-valent) PCV7, PCV13 A. Shoulder Injury Related to Vaccine Administration (7 days)
B. Vasovagal syncope (7 days)
C. Any acute complication or sequelae (including death) of above events (interval - not applicable)
D. Events described in manufacturer’s package insert as contraindications to additional doses of vaccine (interval - see package insert)Hepatitis A in any combination- HepA, HepA-HepB A. Shoulder Injury Related to Vaccine Administration (7 days)
B. Vasovagal syncope (7 days)
C. Any acute complication or sequelae (including death) of above events (interval - not applicable)
D. Events described in manufacturer’s package insert as contraindications to additional doses of vaccine (interval - see package insert)Seasonal influenza--trivalent inactivated influenza, quadrivalent inactivated influenza, live attenuated A. Anaphylaxis or anaphylactic shock (7 days)
B. Shoulder Injury Related to Vaccine Administration (7 days)
C. Vasovagal syncope (7 days)Vaccine/Toxoid Event and interval** from vaccination influenza-IIV, IIV3, IIV4, RIV3, ccIIV3, LAIV4 D. Guillain-Barré Syndrome (42 days)
E. Any acute complication or sequelae (including death) of above events (interval - not applicable)
F. Events described in manufacturer’s package insert as contraindications to additional doses of vaccine (interval - see package insert)Meningococcal - MCV4, MPSV4, Hib-MenCY, MenACWY, MenB A. Anaphylaxis or anaphylactic shock (7 days)
B. Shoulder Injury Related to Vaccine Administration. (7 days)
C. Vasovagal syncope (7 days)
D. Any acute complication or sequelae (including death) of above events (interval - not applicable)
E. Events described in manufacturer’s package insert as contraindications to additional doses of vaccine (interval - see package insert)Human Papillomavirus (Quadrivalent, Bivalent, or 9 valent) - 9vHPV, 4vHPV, 2vHPV A. Anaphylaxis or anaphylactic shock (7days)
B. Shoulder Injury Related to Vaccine Administration (7 days)
C. Vasovagal syncope (7 days)
D. Any acute complication or sequelae (including death) of above events (interval - not applicable)
E. Events described in manufacturer’s package insert as contraindications to additional doses of vaccine (interval - see package insert)Any new vaccine recommended by the Centers for Disease Control and Prevention for routine administration to children A. Shoulder Injury Related to Vaccine Administration (7 days)
B. Vasovagal syncope (7 days)
C. Any acute complication or sequelae (including death) of above events (interval - not applicable)
D. Events described in manufacturer’s package insert as contraindications to additional doses of vaccine (interval - see package insert)* Effective date: March 21, 2017. The Reportable Events Table (RET) reflects what is reportable by law (42 USC 300aa-25) to the Vaccine Adverse Event Reporting System (VAERS) including conditions found in the manufacturer package insert. In addition, healthcare professionals are encouraged to report any clinically significant or unexpected events (even if not certain the vaccine caused the event) for any vaccine, whether or not it is listed on the RET. Manufacturers are also required by regulation (21CFR 600.80) to report to the VAERS program all adverse events made known to them for any vaccine.
Note that the RET differs from the Vaccine Injury Table (VIT) regarding timeframes of adverse events. Timeframes listed on the RET reflect what is required for reporting, but not what is required for compensation.
To view timeframes for compensation, please see the VIT at
VAERS Table of Reportable Events Following Vaccination* Vaccine/Toxoid Event and interval** from vaccination https://www.hrsa.gov/vaccinecompensation/vaccineinjurytable.pdf
**Represents the onset interval between vaccination and the adverse event. For a detailed explanation of terms, see the Vaccine Injury Table at
https://www.hrsa.gov/vaccinecompensation/vaccineinjurytable.pdfA list of vaccine abbreviations is located at: https://www.cdc.gov/vaccines/terms/vacc-abbrev.html
Vaccine Adverse Event Reporting System (VAERS)
Standard Operating Procedures for COVID-19 (as of 4 December 2020)
VAERS Team
Immunization Safety Office, Division of Healthcare Quality Promotion National Center for Emerging and Zoonotic Infectious Diseases Centers for Disease Control and Prevention
COVID-19 vaccines 12
3.0 Coordination and Collaboration 18
but not abstract, and identifying PTs 28
This document is a draft planning document for internal use by the Centers for Disease Control and Prevention, with collaborating contractors. Numerous aspects (including but not limited to specific adverse events to be monitored, timeframes for report processing, data elements to be reported, and data analysis) are dynamic and subject to change without notice.
CDC and FDA will perform routine VAERS surveillance to identify potential new safety concerns for COVID-19 vaccines. This surveillance will include generating tables summarizing automated data from fields on the VAERS form for persons who received COVID-19 vaccines (e.g., age of vaccinee, COVID-19 vaccine type, adverse event).
Enhanced surveillance (i.e., automated data and clinical review) will be implemented after reports of the following adverse events of special interest (AESIs): death, COVID- 19 disease, Guillain-Barre Syndrome (GBS), seizure, stroke, narcolepsy/cataplexy, anaphylaxis, vaccination during pregnancy, acute myocardial infarction, myopericarditis, coagulopathy (including thrombocytopenia, disseminated intravascular coagulopathy [DIC], and deep venous thrombosis [DVT]), Kawasaki’s disease, multisystemic inflammatory syndrome in children (MIS-C), multisystemic inflammatory syndrome in adults (MIS-A), and transverse myelitis. Abstraction of medical records associated with reports of these conditions will be performed using an internal CDC website (i.e., behind CDC’s firewall). Data entered into the abstraction website will be stored on CDC servers and used to populate data tables, from which automated reports will be generated and analyzed on a periodic basis. Enhanced surveillance (i.e., automated data and clinical review) will also be implemented after reports of pregnancy complications, stillbirths, congenital anomalies, and vaccination errors. However, abstraction of medical records after these conditions will be performed on an as needed basis. These efforts will assist in CDC’s efforts to monitor the safety of COVID-19 vaccines.
The Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) use the Vaccine Adverse Event Reporting System (VAERS) as a front-line system to monitor the safety of vaccines licensed for use in the United States. In addition to conducting general surveillance, each year VAERS activities focus on new formulations and types of vaccine, new populations who may be vaccinated because of changes in licensed indications or Advisory Committee on Immunization Practices (ACIP) recommendations, and any new safety concerns identified. This Standard Operating Procedures (SOP) document describes the following activities for COVID-19 vaccine safety monitoring:
The VAERS Team within CDC’s Immunization Safety Office (ISO)
This SOP does not describe details of FDA surveillance procedures for COVID-19 vaccine safety or CDC surveillance or evaluation of COVID-19 vaccines in systems other than VAERS.
[Placeholder for section describing individual COVID-19 vaccines when available]
For each adverse event of special interest (AESI), the rationale for enhanced monitoring, case definitions (if available), and references are provided in Table 1:
Adverse Event of Special Interest | Rationale for enhanced monitoring | Case definition (if available)* | References |
Acute myocardial infarction (AMI) | · Has been reported as a presenting sign of COVID-19 disease and could indicate VAED | · International consensus case definition available at https://www.ahajournals.org/doi/epub |
Anaphylaxis | · Can represent a severe allergy of life-threatening severity · | · Brighton Collaboration case definition available at https://www.sciencedirect.com/scienc e/article/pii/S0264410X07002642?via | · https://www.sciencedirect.com/sci ence/article/pii/S00916749193002 0X?via%3Dihub |
Coagulopathy | · Thrombocytopenia, DIC, and DVT have all been reported as part of COVID-19 disease and could indicate VAED | · Brighton Collaboration case definition for thrombocytopenia available at https://www.sciencedirect.com/scien ce/article/pii/S0264410X0700268X? via%3Dihub · Scientific Standardization Committee of the International Society of Thrombosis and Haemostasis scoring for DIC available at https://www.tandfonline.com/doi/ful l/10.1080/17474086.2018.1500173
· Modified Wells’ score (widely acknowledged standard for DVT/PE) available at https://academic.oup.com/clinchem/ar ticle/57/9/1256/5620938 | · https://www.thelancet.com/journal s/lanhae/article/PIIS2352- 3026(20)30151-4/fulltext |
COVID-19 disease | · COVID-19 disease can be an indication of vaccine failure
· Severe COVID-19 disease can be an indication of vaccine-enhanced disease (VAED) | · CSTE case definition for COVID-19 available at https://wwwn.cdc.gov/nndss/conditio ns/coronavirus-disease-2019-covid- 19/case-definition/2020/08/05/ · Pre-publication Brighton case definition for VAED available at https://brightoncollaboration.us/vaed/ | |
Death | · Public interest in deaths after vaccination, especially in children (<18 years of age) and recipients of newly licensed vaccines | · Report of death certificate or autopsy report | |
GBS | · Is a vaccine-associated adverse event of historical interest | · Brighton Collaboration case definition available at https://www.sciencedirect.com/scienc e/article/pii/S0264410X1000798X?vi a%3Dihub | |
Kawasaki’s disease | · Could be confused with MIS-C, which could be an indication of VAED | · CDC case definition available at https://www.cdc.gov/kawasaki/case- definition.html |
Multisystem Inflammatory Syndrome in Children (MIS- C) | · Could be an indication of VAED | · Interim case definition available at https://www.cdc.gov/mmwr/volumes/ 69/wr/mm6932e2.htm | |
Multisystem Inflammatory Syndrome in Adults (MIS-A) | · Could be an indication of VAED | · Interim case definition available at https://www.cdc.gov/mmwr/volumes/ 69/wr/mm6940e1.htm | |
Myopericarditis | · Has been reported as part of COVID-19 disease pathology and could indicate VAED | · Joint Smallpox Vaccine Safety Working Group of the Advisory Committee on Immunization Practices (ACIP) and the Armed Forces Epidemiology Board (AFEB) case definition available at https://www.cdc.gov/mmwr/PDF/wk/ mm5221.pdf (p. 494) | |
Narcolepsy/ Cataplexy | · Has been alleged as an adverse event associated with some adjuvanted vaccines; some COVID-19 vaccines might employ adjuvants | · Brighton Collaboration case definition available at https://www.sciencedirect.com/scienc e/article/pii/S0264410X12017811?via | · https://www.cdc.gov/vaccinesafety /concerns/history/narcolepsy- flu.html · https://www.hhs.gov/about/news/2 020/07/31/hhs-dod-partner-sanofi- gsk-commercial-scale- manufacturing-demonstration- project-produce-millions-covid- 19-investigational-vaccine- doses.html |
Vaccination during pregnancy | · Public interest and concern over adverse pregnancy events and fetal outcomes | · Report of vaccinated person being pregnant (during or after vaccination) | · http://www.sciencedirect.com/scie nce/article/pii/S000293781001105 1 · |
Seizure | · Is a vaccine-associated adverse event of historical interest
· In young patients (i.e., 5 years and younger) might indicate febrile seizure | · Brighton Collaboration case definition available at https://www.sciencedirect.com/scienc e/article/pii/S0264410X03006613?via | |
Stroke | · Has been reported with COVID-19 disease and might therefore be an indication of VAED
· Was also reported in a COVID-19 vaccine prelicensure clinical trial | · American Heart Association/American Stroke Association consensus definition available at https://www.ahajournals.org/doi/epub | · https://jamanetwork.com/journals/j amaneurology/fullarticle/2768098 · https://www.washingtonpost.com/ health/2020/10/23/jj-vaccine-trial- to-resume/ |
Transverse myelitis | · One report of transverse myelitis observed in prelicensure clinical trial of ChAdOx1 nCoV-19 vaccine. | · No case definition exists; will track on the basis of physician diagnosis | · https://www.npr.org/sections/coron avirus-live- updates/2020/09/12/912281381/ast razeneca-resumes-its-covid-19- vaccine-trials-in-the-u-k |
For details on the background, historical perspective and specific aims of VAERS surveillance, access https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vaers/index.html.
In addition, selected AESIs will be monitored for awareness but not abstracted. These AESIs and available case definitions are listed in Table 2:
AESIs to monitor but not abstract* | Reference definitions and available case definitions |
Acute Respiratory Distress Syndrome (ARDS) | https://www.thoracic.org/professionals/career-development/residents- medical-students/ats-reading-list/adult/ards.php |
Autoimmune disorders | Appendix 4.6 lists specific disorders to monitor |
Other clinically serious neurologic AEs: |
|
Acute disseminated encephalomyelitis (ADEM) | |
Multiple sclerosis (MS) | |
Optic neuritis (ON) | |
Chronic inflammatory demyelinating polyneuropathy (CIDP) | Gogia et al (last updated 9 Oct 2020) |
Encephalitis | |
Myelitis | |
Encephalomyelitis | |
Meningoencephalitis | |
Meningitis | |
Encephalopathy | |
Ataxia | Johns Hopkins Medicine Dept of Neurology and Neurosurgery (last accessed 7 Nov 2020) |
Non-anaphylactic allergic reactions | Varies with specific symptom; see Appendix 4.6 |
Vaccination errors | See Section 4.4 |
The specific tasks and frequency of these tasks for surveillance will be adjusted to meet public health needs, with consideration of staff time and resources. For example, in the event of a significant increase in the number of adverse events (AEs) reported to VAERS that warrant clinical review, additional ISO staff will be assigned to perform reviews. An algorithm of the process to monitor vaccine AEs is shown in Appendix 4.1.
CDC will perform clinical reviews for AESIs listed in Table 1. Results from automated data assessment will identify additional conditions potentially warranting further clinical review.
CDC will perform Proportional Reporting Ratio (PRR) analysis (see section 2.3.1, p. 14), excluding laboratory results, to identify AEs that are disproportionately reported relative to other AEs.
FDA routinely reviews all serious* and other medically important condition (OMIC) reports daily and performs data mining.
Summaries (or other deliverables, as needed) will be based on data processing, coding and follow-up, automated data, and clinical review, as well as field investigations as appropriate. COVID-19 vaccine safety coordination meetings among ISO team members and FDA will be scheduled weekly (or more frequently, as needed) to discuss results of the automated data and (if indicated) clinical review.
The CDC contractor for VAERS receives, processes, and manages VAERS reports. The contractor receives reports online and by mail, fax, or telephone. Using standard procedures, contractor staff will review each U.S. report following COVID-19 vaccines and assign standard codes to each reported sign, symptom, and diagnosis using Medical Dictionary for Regulatory Activities terminology [10]. The staff will enter all MedDRA terms and other information from each VAERS report form into a computerized database. Vaccine type codes in the VAERS database are shown in Appendix 4.2.
Trained contractor staff will request additional information including hospital records and autopsy reports when appropriate (Appendices 4.3 and 4.4). Medical records are routinely requested for all serious reports, including deaths.
Contractor clinical staff will summarize data and assign additional MedDRA codes for symptoms, signs, and diagnoses identified from the requested additional information.
They will then add these additional codes to the data originally entered into the database for the specific VAERS report.
Table 3 lists the AESIs for which medical records will be requested and reviewed. Manual review of serious reports is routinely performed by FDA (a more in-depth clinical review will be performed by CDC as indicated).
AESI | Medical and vaccination records obtained by contractor | Clinical review by CDC* |
Acute Myocardial Infarction (AMI) |
All reports (including manufacturer reports) |
All reports (including manufacturer reports) |
Anaphylaxis | ||
Coagulopathy | ||
COVID-19 disease | ||
Death | ||
GBS | ||
Kawasaki’s disease | ||
Multisystem Inflammatory Syndrome in Children (MIS-C) | ||
Multisystem Inflammatory Syndrome in Adults (MIS-A) | ||
Myopericarditis | ||
Narcolepsy/ Cataplexy | ||
Non-Death Serious | All reports (including manufacturer reports) | As needed |
Pregnancy and Prespecified Conditions |
All reports (including manufacturer reports) |
All reports (including manufacturer reports) |
Seizure/Convulsion | ||
Stroke | ||
Transverse myelitis |
*Includes review of VAERS form and available medical records by primary ISO staff. Initial review will be performed and documented within CDC internal COVID-19 medical abstraction website. More detailed review will be performed as needed
All COVID-19 vaccine reports will be entered into the VAERS database and assigned a unique identifying (ID) VAERS number during normal business hours. The contractor will send daily e-mail alerts (Daily Priority Reports) to CDC/FDA with a list of VAERS ID numbers for all serious and non-serious reports of adverse events of special interest (AESIs) after COVID-19 vaccines. Reports of AESIs will be identified in the Daily Priority Reports and in a daily table (to be constructed, as described in section 2.4).
Appendix 4.3 provides details on how the prespecified conditions will be identified by the contractor.
ISO will make selected VAERS data available to Vaccine Safety Coordinators (VSCs) in requesting jurisdictions on a weekly basis via Epi-X. The selected data will include the following:
Residence within a local jurisdiction will be determined in similar fashion, based upon city and ZIP code information comprising the local jurisdiction.
Weekly redacted data will be made available publicly via CDC WONDER (https://wonder.cdc.gov/), HHS (https://vaers.hhs.gov ), and Epi-X on the same date. Case counts on Epi-X and public websites should be equal; any differences in case counts may result from data processing (e.g., data cleaning) and will be reconciled as the data mature.
Reports of vaccination errors will be identified by conducting an automated search using MedDRA preferred terms (PTs) and organized into vaccination error groups shown in Appendix 4.5.
Vaccination errors will be summarized by vaccination error group based on automated data and include any error involving COVID-19 vaccines and any other coadministered vaccine(s). Clinical review of VAERS reports will be performed for vaccination error reports that are classified as serious (see p.11) , and vaccination error PTs with elevated PRRs.
The data from this automated search will be provided as a weekly automated table that will be reviewed as described below in sections 2.4 and 3.0.
A series of tables will be generated using the VAERS automated data.
A version of the cumulative count tables from section 2.1.1 will be refreshed daily for internal use (i.e., inside ISO). This version will be generated independently of the jurisdictional Epi-X/CDC WONDER data and will be almost identical in appearance and content, except that the data will be presented in aggregate and not at the local level..
Because this internal version will use supplemental data not for public release, counts may vary from counts on Epi-X/CDC WONDER.
Data tables demonstrating frequency, reporting ratios and general characteristics will be generated automatically using pre-defined variables populated by VAERS data. The data in these tables will be summarized by whether the AE is classified as serious and by age group and sex, and will be presented in weekly and cumulative formats.
The following weekly tables will be available every Monday (data as of the previous Friday):
Table 1. All reports following COVID-19 vaccines by severity and selected manufacturer/brand name
AESI tables
Table 2. Top 25 most frequently reported AEs
Table 3. Reports of the following AESIs after vaccination with COVID-19 vaccines, stratified by age group (ages <18 years, 18–49 years, 50–64 years, 65–74 years, 75+ years, unreported):
Table 4. Reporting trends of the following AESIs after vaccination with COVID-19 vaccines, stratified
by age group (<12 months, 12–35 months, 36–59 months, 5–11 years, 12–20 years, >20 years, unreported)
Table 5. Reporting trends of VACCINATION DURING PREGNANCY following vaccination with COVID-19 vaccines stratified by age group (ages <18 years, 18–29 years, 30–39 years, 40–49 years, ≥50 years, unreported)
Table 6. Reporting trends of Autoimmune Disorders by System Organ Class following vaccination with COVID-19 vaccines by age group (ages <18 years, 18–49 years, 50–64 years, 65–74 years, 75+ years, unreported)
Table 7. Reporting trends of AESIs to monitor but not abstract (Table 2, p. 8), following vaccination with COVID-19 vaccines by age group (ages <18 years, 18–49 years, 50–64 years, 65–74 years, 75+ years, unreported)
Table 8. Vaccination errors
Table 9, 10, etc. PRRs (number of tables TBD)
The analyses for COVID-19 vaccine safety signals will focus on identifying deviations from preliminary safety data, and possibly from other vaccines, using disproportionality analyses and comparisons of reporting rates.
Two main approaches to data mining are Proportional Reporting Ratios (PRRs) and Empirical Bayesian Geometric Means [11–13]. Both have published literature suggesting criteria for detecting “signals” [14]. PRR will be used at CDC for potential signal detection; Empirical Bayesian data mining will be performed by FDA.
After initial licensure or approval of COVID-19 vaccines in the United States, initial reports may be too few to allow for data mining immediately. As the data mature, PRR and Empirical Bayesian data mining can then be used.
CDC will perform PRR data mining on a weekly basis or as needed. PRRs compare the proportion of a specific AE following a specific vaccine versus the proportion of the same AE following receipt of another vaccine (see equation below Table 4). A safety signal is defined as a PRR of at least 2, chi-squared statistic of at least 4, and 3 or more cases of the AE following receipt of the specific vaccine of interest.
CDC will apply appropriate comparator vaccines (e.g., adjuvanted vaccines like Shingrix and/or Fluad for adjuvanted COVID-19 vaccines) and adjust for severity and age distributions where applicable.
| Specific AE | All other AE |
Specific vaccine | A | B |
All other vaccines | C | D |
PRR = [a/(a+b)]
[c/(c+d)]
FDA will perform data mining at least biweekly (with stratified data mining monthly) using empirical Bayesian data mining to identify AEs reported more frequently than expected following vaccination with COVID-19 vaccines, using published criteria [12, 14]. Vaccine product-specific AE pairs following specific COVID-19 vaccines with reporting proportions at least twice that of other vaccines in the VAERS database (i.e., lower bound of the 90% confidence interval of the Empirical Bayesian Geometric Mean [EB05] >2) will be evaluated. Data mining runs can be adjusted and/or stratified by possible confounding variables such as age, sex, season of administration, and type of vaccines. FDA and CDC will share and discuss results of data mining analyses and signals.
If needed for internal purposes, crude reporting rates will be calculated based on COVID- 19 vaccine doses distributed, when a source of doses distributed data becomes available.
MedDRA terms identified as safety signals due to elevated PRR and/or a stastistically significant finding on data mining will be reviewed as appropriate. The pattern or trend of PRR and data mining results over a period of time (e.g., several weeks) will be monitored before initiating a clinical review. Other factors, such as clinical importance, whether AEs are unexpected, seriousness, and whether a specific syndrome or diagnosis is identified rather than non-specific symptoms will be considered in determining if clinical review will be performed.
Identification of a cluster of reports or unexpected AEs will be further investigated, and additional information on serious AEs will be shared with CDC leadership. A list of lot numbers of vaccines that may be of concern will be requested from FDA. In the event of review of difficult or rare cases, subject matter experts (e.g., neurologist, the Clinical Immunization Safety Assessment network) may be consulted.
Clinical review will include reviewing reports (and associated medical records) containing the identified MedDRA terms, confirming appropriate coding, confirming diagnosis (e.g., by applying a case definition), confirming time from vaccination to symptom onset, reviewing the patient history and course of illness to identify risk factors, and potentially comparing to comparable data for another vaccine.
A summary of the data review described in this section will be provided monthly, or as needed, to pertinent stakeholders (e.g., Immunization Safety Office leadership, FDA partners).
Signal detection can occur in VAERS surveillance through FDA empirical Bayesian data mining, through CDC PRR data mining, and through descriptive analysis. When a potential signal is detected, ISO VAERS staff shall take a series of steps to assess the potential signal. Steps may include, but are not limited to:
If, after an initial assessment, VAERS investigators determine a signal warrants further investigation, the VAERS team lead will notify ISO leadership and develop a coordinated response plan. Any appropriate investigation will be conducted in collaboration with FDA. FDA will share with CDC reports of possible concern based of the data mining results and assess product-specific or lot safety as appropriate. ISO leadership will be responsible for notifying NCIRD and the CDC COVID-19 Vaccine Task Force (VTF) in a timely manner.
Meetings and conference calls will be scheduled as follows, subject to change as needed:
with ISO leadership, NCIRD representatives, and FDA
Vaccine type | CDC code | Notes |
(Fill as appropriate) |
|
|
Criteria | Actions/ Documents Requested | ||
Description | Report Type | Vaccine Brand/Manufacturer | |
All | Serious (including manufacturer reports) | Unknown/ Not Specified | Vaccination records |
|
| MedDRA Codes or Text Search |
|
Acute Myocardial Infarction | Serious/Non-serious (including manufacturer reports) | MedDRA Codes: Acute myocardial infarction Myocardial infarction Silent myocardial infarction | Clinical follow-up Vaccination records |
Anaphylaxis | Serious/Non-serious (including manufacturer reports) | MedDRA Codes: Anaphylactic reaction Anaphylactic shock Anaphylactoid reaction Anaphylactoid shock | Clinical follow-up Vaccination records |
COVID-19 Disease | Serious/Non-serious (including manufacturer reports) | COVID-19 Asymptomatic COVID-19 COVID-19 pneumonia | Clinical follow-up Vaccination records |
Coagulopathy | Serious/Non-serious (including manufacturer reports) | MedDRA Codes: Acquired amegakaryocytic thrombocytopenia Amegakaryocytic thrombocytopenia Axillary vein thrombosis Cavernous sinus thrombosis Cerebral venous thrombosis Deep vein thrombosis Disseminated intravascular coagulation Embolism venous Hepatic vein thrombosis Immune thrombocytopenia Intracranial venous sinus thrombosis Mesenteric vein thrombosis Portal vein thrombosis Pulmonary embolism Pulmonary thrombosis | Clinical follow-up Vaccination records |
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| Pulmonary venous thrombosis Severe fever with thrombocytopenia syndrome Subclavian vein thrombosis Thrombocytopenia Thrombocytopenic purpura Thrombotic thrombocytopenic purpura Thrombosis Transverse sinus thrombosis Vena cava embolism Vena cava thrombosis Venous thrombosis |
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GBS | Serious/Non-serious (including manufacturer reports) | MedDRA Codes: Guillian-Barre syndrome Miller Fisher syndrome Demyelinating polyneuropathy | Clinical follow-up Vaccination records Do NOT fill out GBS questionnaire |
Kawasaki Disease | Serious/Non-serious (including manufacturer reports) | MedDRA Codes: Kawasaki's disease | Clinical follow-up Vaccination records |
Multisystem Inflammatory Syndrome in Children (MIS-c) | Serious/Non-serious (including manufacturer reports) | Ages 0-20 AND MedDRA Codes: Multisystem inflammatory syndrome in children | Clinical follow-up Vaccination records |
Multisystem Inflammatory Syndrome in Adults (MIS-a) | Serious/Non-serious (including manufacturer reports) | Ages 21 and older AND MedDRA Codes: TBA | Clinical follow-up Vaccination records |
Myocarditis/Pericarditis | Serious/Non-serious (including manufacturer reports) | MedDRA Codes: Atypical mycobacterium pericarditis Autoimmune myocarditis Autoimmune pericarditis Bacterial pericarditis Coxsackie myocarditis Coxsackie pericarditis Cytomegalovirus myocarditis Cytomegalovirus pericarditis Enterovirus myocarditis | Clinical follow-up Vaccination records |
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| Eosinophilic myocarditis Hypersensitivity myocarditis Immune-mediated myocarditis Myocarditis Myocarditis bacterial Myocarditis helminthic Myocarditis infectious Myocarditis meningococcal Myocarditis mycotic Myocarditis post infection Myocarditis septic Pericarditis Pericarditis adhesive Pericarditis constrictive Pericarditis helminthic Pericarditis infective Pericarditis mycoplasmal Pleuropericarditis Purulent pericarditis Viral myocarditis Viral pericarditis |
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Narcolepsy/Cateplexy | Serious/Non-serious (including manufacturer reports) | MedDRA Codes: Narcolepsy Cataplexy | Clinical follow-up Vaccination records |
Pregnancy and Prespecified Conditions | Serious/Non-serious (including manufacturer reports) | MedDRA Codes: Abortion Aborted pregnancy Abortion complete Abortion early Abortion incomplete Abortion late Abortion missed Abortion spontaneous Abortion spontaneous complete Abortion spontaneous incomplete Abortion threatened Congenital anomaly | Clinical follow-up including: prenatal visit documentation, delivery records, ER/hospital records during pregnancy, well child visits, infant hospitalization records; for congenital anomalies- infant records, ultrasounds, genetic studies |
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| Drug exposure during pregnancy Exposure during pregnancy Foetal death Maternal exposure during pregnancy Stillbirth OR Text String: Preg (Text String located in symptom_text, history, prex_illness) OR Pregnant Status (2.0 form-Q8) OR Congenital anomaly outcome (2.0 form-Q21) | Vaccination records |
Seizure/Convulsion | Serious/Non-serious (including manufacturer reports) | MedDRA Codes: Atonic seizures Atypical benign partial epilepsy Autonomic seizure Clonic convulsion Complex partial seizures Convulsion in childhood Convulsion Convulsions local Epilepsy Epileptic encephalopathy Febrile convulsion Febrile infection-related epilepsy syndrome Generalised non-convulsive epilepsy Generalised onset non-motor seizure Generalised tonic-clonic seizure Grand mal convulsion Idiopathic generalised epilepsy Myoclonic epilepsy Neonatal seizure Partial seizures with secondary generalisation Partial seizures Petit mal epilepsy Seizure anoxic | Clinical follow-up Vaccination records |
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| Seizure cluster Seizure like phenomena Seizure Simple partial seizures Status epilepticus Temporal lobe epilepsy Tonic clonic movements Tonic convulsion Tonic posturing |
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Stroke | Serious/Non-serious (including manufacturer reports) | MedDRA Codes: Basal ganglia stroke Brain stem stroke Cerebellar stroke Cerebrovascular accident Embolic stroke Haemorrhagic stroke Haemorrhagic transformation stroke Ischaemic stroke Lacunar stroke Perinatal stroke Spinal stroke Thrombotic stroke Vertebrobasilar stroke | Clinical follow-up Vaccination records |
Transverse myelitis | Serious/Non-serious (including manufacturer reports) | MedDRA Codes: Myelitis transverse | Clinical follow-up Vaccination records |
Type of report | Reported Vaccine | Serious reports | Serious follow-up initiation | Non-serious reports | ||
Scan within | Complete process within3 | Scan within | Complete process within3 | |||
1. US Deaths4 | COVID-19 | 1 | 1 | 1 | N/A | N/A |
2. US Deaths4 | Non-COVID-19 | 2 | 2 | 2 | N/A | N/A |
3. US/Foreign 5-day | All | 2 | 2 | N/A | N/A | N/A |
4. US 15-day | All | 2 | 2 | N/A | N/A | N/A |
5. US | COVID-195 | 2 | 3 | 3 | 2 | 5 |
6. US | Seasonal Influenza6,7 | 2 | 4 | 4 | 2 | 10 |
7. US 30-day | All | 2 | 20 | N/A | 2 | 30 |
8. US | List A6 | 2 | 20 | 20 | 2 | 30 |
9. US | List B | 2 | 30 | 20 | 2 | 45 |
10. Foreign Deaths | COVID-19 | 2 | 2 | N/A | N/A | N/A |
11. Foreign | COVID-19 | 2 | 30 | N/A | 5 | 120 |
12. Foreign | Non-COVID-19 | 5 | 90 | N/A | 5 | 120 |
List A | List B |
HEPLISAV-B Shingrix Gardasil 9 Yellow Fever Other vaccines licensed in the U.S. for less than 12 months Seasonal Influenza reports received after March 31, 2021 | All vaccines excluding List A and Seasonal Influenza |
Administration Errors
Contraindication to vaccination
Equipment
General
Inappropriate schedule of drug administration
Incorrect dose
Prescribing and dispensing
Product quality
Wrong Product
VAERS COVID-19
Prespecified Conditio
(The embedded Excel spreadsheet documents PTs for all AESIs, both abstracted and monitored, but not asbtracted.)
AESI | Identifying MedDRA PT(s) |
Acute Respiratory Distress Syndrome (ARDS) | Acute Respiratory Distress Syndrome |
Autoimmune disorders | [see embedded spreadsheet] |
Other clinically serious neurologic AEs: |
|
Acute disseminated encephalomyelitis (ADEM) | Acute disseminated encephalomyelitis |
Multiple sclerosis (MS) | Multiple sclerosis Multiple sclerosis relapse Primary progressive multiple sclerosis Progressive multiple sclerosis Progressive relapsing multiple sclerosis Relapsing multiple sclerosis Relapsing-remitting multiple sclerosis Secondary progressive multiple sclerosis Tumefactive multiple sclerosis |
Optic neuritis (ON) | Optic neuritis |
Chronic inflammatory demyelinating polyneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy |
Encephalitis | Encephalitis |
Myelitis | Myelitis |
Encephalomyelitis | Encephalomyelitis Leukoencephalomyelitis Noninfective encephalomyelitis |
Meningoencephalitis | Meningoencephalitis viral |
Meningitis | Meningitis Meningitis aseptic Meningitis viral |
Encephalopathy | Encephalopathy Leukoencephalopathy |
Ataxia | Ataxia Cerebellar ataxia Cerebral ataxia |
Non-anaphylactic allergic reactions | Allergic reaction to excipient Allergy to vaccine Allergic bronchitis Allergic colitis Allergic cough Allergic cystitis Allergic gastroenteritis Allergic hepatitis Allergic keratitis Allergic pharyngitis Allergic reaction to excipient Allergic respiratory disease Allergic respiratory symptom Allergic sinusitis Conjunctivitis allergic Dermatitis allergic Encephalitis allergic Encephalopathy allergic Laryngitis allergic Nephritis allergic Pruritus allergic Rhinitis allergic Scleritis allergic |
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