Adverse Effects of Vaccines Evidence and Causality (2012) / Chapter Skim
Currently Skimming:
12 Injection-Related Adverse Events
12 Injection-Related Adverse Events
Pages 615-628
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 615... ...
Mechanistic Evidence The committee identified 10 publications reporting the development or exacerbation of CRPS after receiving an injection. Eight publications described cases that did not provide evidence beyond temporality (Bensasson et al., 1977; Genc et al., 2005; Jastaniah et al., 2003; Kachko et al., 2007; Palao Sanchez et al., 1997; Pirrung, 2010; Siegfried, 1997; Steinberg et al., 615
|
From page 616... ...
These publications did not contribute to the weight of mechanistic evidence. Described below are publications reporting clinical, diagnostic, or experimental evidence that contributed to the weight of mechanistic evidence.
|
From page 617... ...
did not include convincing evidence beyond a temporal relationship between injection of a vaccine and development of CRPS. The committee assesses the mechanistic evidence regarding an as sociation between the injection of a vaccine and CRPS as low intermediate based on experimental evidence and one case.
|
From page 618... ...
Mechanistic Evidence The committee identified three publications and three Vaccine Adverse Event Reporting System (VAERS) reports describing the development of deltoid bursitis after administration of a vaccine by injection.
|
From page 619... ...
Weight of Mechanistic Evidence The publications, described above, presented clinical evidence sufficient for the committee to conclude that the injection of a vaccine was a contributing cause of deltoid bursitis. The clinical descriptions provided by
|
From page 620... ...
The committee assesses the mechanistic evidence regarding an as sociation between the injection of a vaccine and deltoid bursitis as strong based on 16 cases presenting definitive clinical evidence. Causality Conclusion Conclusion 12.2: The evidence convincingly supports a causal relationship between the injection of a vaccine and deltoid bursitis.
|
From page 621... ...
, to the Serious Adverse Events Following Vaccination Surveillance Scheme (SAFEVSS) , and to the Adverse Drug Reactions Advisory Committee (ADRAC)
|
From page 622... ...
Case 3 describes a 26-year-old man who developed syncope less than 3 minutes after receiving tetanus-diphtheria and measles, mumps, and rubella vaccines. The patient suffered a linear nondepressed skull fracture and contusions of the frontal and temporal regions.
|
From page 623... ...
(2010) conducted a randomized trial of an alternate human papillomavirus vaccine administration schedule and received 114 and 95 reports of adverse events in the standard schedule group and the alternate schedule group, respectively.
|
From page 624... ...
Causality Conclusion Conclusion 12.3: The evidence convincingly supports a causal re lationship between the injection of a vaccine and syncope. CONCLUDING SECTION Table 12-1 provides a summary of the epidemiologic assessments, mechanistic assessments, and causality conclusions for injection-related adverse events.
|
From page 625... ...
In addition, hundreds of cases have been reported to passive surveillance systems; however, it is not possible to known how many represent unique cases or were reported elsewhere.
|
From page 626... ...
2010. Descriptive summary of VAERS reports indicat ing serious adverse events following influenza vaccination discussed in Safety of trivalent inactivated influenza vaccines in adults: Background for pandemic influenza vaccine safety monitoring.
|
From page 627... ...
2004. Abnormal contralateral pain responses from an intradermal injection of phenylephrine in a subset of patients with complex regional pain syndrome (CRPS)
|
From page 628... ...
2009. Safety of trivalent inactivated influenza vaccines in adults: Background for pandemic influenza vaccine safety monitoring.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.