Ultrasound and Immunological Findings in Patients With Shoulder Injury Related to Vaccine Administration (SIRVA)

University Hospital, Basel, Switzerland30 enrolled

Overview

Accidental vaccine injection into adjunct shoulder structures can cause tissue damage, termed Shoulder injury related to vaccine administration (SIRVA). The immunopathological mechanisms and consequences of SIRVA are unknown. The study assesses the clinical and immunological consequences of an influenza vaccine if accidentally administered in periarticular space.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Shoulder Injury Related to Vaccine Administration Erosion, Localized

Interventions

Ultrasound Shoulder and Immunological Phenotyping by FACSDIAGNOSTIC_TEST

Cross-sectional Ultrasound exam of the affected shoulder. Peripheral blood measurements of the T and B cell subsets. Anti-Influenza Antibody measurements

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * participation at a local vaccination campaign * Shoulder pain \>3 days after vaccination Exclusion Criteria: * no vaccine received * preexisting shoulder pathology

Locations (1)

University Hospital Basel

Basel, Switzerland

Outcomes

Primary Outcomes

Pathological Findings in Ultrasound

Cross-sectional assessment and description of pathological ultrasound findings in subjects with shoulder pain after influenza vaccination

Time frame: Ultrasound of the shoulder is performed at Baseline/Inclusion

Secondary Outcomes

Increased Vaccine response

Antibodies against Influenza, Plasmablasts and T follicular helper cell increase

Time frame: Baseline and 12 months

Data from ClinicalTrials.gov

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