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unexpected AEs and local vs systemic events, based on the risk profile of the intervention/investigational product. This information is found on the IB or package insert. Typically, reactogenicity AEs are solicited and collected on memory cards and documented on a reactogenicity CRF. This information comes from the participant who may also have a memory aid to help recollect their symptoms.
88:, which would require hospitalization or are life-threatening. Adverse events have been linked to a higher degree of reactogenicity; however, the links might have been coincidental. After assessing large databases relating to these events for many years, the FDA has not been able to make such a correlation.
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Reactogenicity events are AEs that are common and known to occur for the intervention/investigational product being studied and should be collected in a standard, systematic format using a grading scale based on functional assessment or magnitude of reaction. Provide a definition of expected vs
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to produce common, "expected" adverse reactions, especially excessive immunological responses and associated signs and symptoms, including fever and sore arm at the injection site. Other manifestations of reactogenicity typically identified in such trials include
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that is present in a vaccine. Reactogenicity describes the immediate short-term reactions of a system to vaccines and should not be confused with the long-term consequences
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The following is an example of a functional scale for assessing reactogenicity or other parameters not specifically listed in the toxicity table:
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Hervé, Caroline; Laupèze, Béatrice; Del
Giudice, Giuseppe; Didierlaurent, Arnaud M.; Tavares Da Silva, Fernanda (24 September 2019).
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80:. Assessments of reactogenicity are carried out to evaluate the safety and usability of an experimental vaccine (see
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68:(FDA). All vaccines can induce reactogenicity, but reactogenicity is more likely in vaccines containing an
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Hypothesised link between the innate immune response induced by vaccination and reactogenicity
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2 = Moderate (discomfort enough to cause interference with usual activity)
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108:(NIH) has provided the following definition of reactogenicity:
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Mechanisms underlying the cause of reactogenicity symptoms
1332:Cedillo v. Secretary of Health and Human Services
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163:"The how's and what's of vaccine reactogenicity"
265:The how’s and what’s of vaccine reactogenicity
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64:The term reactogenicity was coined by the US
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119:0 = Absence of the indicated symptom
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1359:Eradication of infectious diseases
1116:Androvax (androstenedione albumin)
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949:Respiratory syncytial virus (RSV)
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1338:Alternative vaccination schedule
308:Artificial induction of immunity
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1170:Ovandrotone albumin (Fecundin)
211:"DMID Interventional Template"
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16:Expected reaction to a vaccine
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701:Group B streptococcal disease
520:Vaccines for Children Program
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106:National Institutes of Health
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696:Clostridioides difficile
82:Investigational New Drug
959:Tick-borne encephalitis
1369:List of vaccine topics
364:Mathematical modelling
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101:
24:
1364:Vaccinate Your Family
815:Japanese encephalitis
127:4 = Life-threatening
110:
99:
35:is the capacity of a
22:
1247:John Franklin Enders
216:. NIH. 25 March 2011
428:Virus-like particle
352:Vaccine ingredients
1404:Never to phase III
1203:Hexavalent vaccine
1017:Epstein–Barr virus
912:Oxford–AstraZeneca
600:NmVac4-A/C/Y/W-135
249:has a profile for
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25:
1414:
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1326:Vaccines and SIDS
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1212:
987:Hepatitis A and B
963:Varicella zoster
420:Subunit/component
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139:Vaccine hesitancy
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1305:MMR autism fraud
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1237:Hilary Koprowski
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1098:Schistosomiasis
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1198:DTwP-HepB-Hib
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1188:DTaP-IPV/Hib
979:Yellow fever
892:EpiVacCorona
644:Tuberculosis
617:Pneumococcal
585:Lyme disease
413:Heterologous
312:Immunization
268:
251:
218:. Retrieved
205:
170:
167:npj Vaccines
166:
112:
103:
63:
32:
26:
1437:Drug safety
1427:Vaccination
1390:from market
1286:Controversy
1220:researchers
1136:Hepatitis B
1022:Hepatitis C
967:Chicken pox
793:Hepatitis E
788:Hepatitis B
783:Hepatitis A
729:Chikungunya
706:Shigellosis
560:Brucellosis
446:Therapeutic
400:Inactivated
340:Development
328:Inoculation
320:Vaccination
1421:Categories
1321:Thiomersal
1267:Paul Offit
1242:Jonas Salk
1218:Inventors/
1089:research:
1066:research:
1003:research:
932:Skycovione
922:Sanofi–GSK
867:SARS-CoV-2
778:Hantavirus
739:rVSV-ZEBOV
724:Adenovirus
692:research:
570:Diphtheria
408:Attenuated
254:(Q7300322)
220:30 January
145:References
92:Definition
50:induration
1400:Phase III
1388:Withdrawn
1316:Pox party
1126:ALVAC-CEA
1048:Protozoan
937:Sputnik V
887:CoronaVac
857:Rotavirus
755:Pandemrix
607:Pertussis
548:Bacterial
432:Synthetic
395:Conjugate
347:Adjuvants
324:Infection
173:(1): 39.
1158:Prostvac
1151:Gardasil
1146:Cervarix
1093:Hookworm
972:Shingles
954:Smallpox
872:Corbevax
808:Gardasil
803:Cervarix
541:Vaccines
495:Schedule
466:Global:
374:Timeline
316:Vaccines
197:31583123
133:See also
78:sequelae
70:adjuvant
54:swelling
42:bruising
1347:Related
1293:General
1055:Malaria
942:Valneva
907:Novavax
902:Moderna
897:Janssen
882:CanSino
862:Rubella
820:Measles
686:Td/Tdap
656:Typhoid
639:Tetanus
634:Q fever
565:Cholera
555:Anthrax
424:Peptide
388:Classes
369:Storage
247:Scholia
188:6760227
104:The US
74:antigen
46:redness
37:vaccine
1383:WHO-EM
1303:Lancet
1180:TA-NIC
1165:NicVAX
1012:Dengue
852:Rabies
673:Typhus
612:Plague
490:Policy
451:Toxoid
379:Trials
273:(2019)
270:Nature
214:(docx)
195:
185:
60:Origin
52:, and
1311:NCVIA
1175:TA-CD
1109:Other
1060:RTS,S
840:Sabin
835:Polio
830:Mumps
734:Ebola
717:Viral
666:ViCPS
661:Ty21a
595:MeNZB
525:VAERS
475:NITAG
404:Live
1037:Zika
997:MMRV
845:Salk
825:Mpox
771:LAIV
766:H5N8
761:H5N1
751:H1N1
627:PPSV
510:ACIP
506:US:
480:SAGE
441:mRNA
357:list
222:2021
193:PMID
1298:MMR
1141:HPV
1131:BCG
1032:HIV
992:MMR
798:HPV
746:Flu
649:BCG
622:PCV
575:Hib
530:VSD
437:DNA
332:J07
183:PMC
175:doi
27:In
1423::
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430:/
426:/
422:/
326:,
322:,
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310:/
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153:^
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330:(
300:e
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258:.
224:.
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177::
171:4
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