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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
A 51-year-old woman developed anaphylactic reaction following administration of elasomeran for vaccination against COVID-19, and exhibited progression of prolonged QT syndrome during treatment with epinephrine for anaphylactic reaction. Additionally, she exhibited lack of efficacy to methylprednisolone, diphenhydramine and famotidine during treatment for anaphylactic reaction [routes, dosages and duration of treatments to reaction onsets not stated; not all outcomes stated].
The woman, who had congenital prolonged QT syndrome of unknown genotype (baseline corrected QT interval-QTc 470ms) and secondary prevention single chamber implantable cardioverter defibrillator in situ, received first dose of the elasomeran [Moderna COVID-19 vaccine]. Subsequently, she developed an anaphylactic reaction and was admitted.
The woman was treated with multiple doses of epinephrine with methylprednisolone [Solu-Medrol], famotidine and diphenhydramine [Benadryl] for anaphylactic reaction. Her anaphylactic symptoms were refractory to methylprednisolone, diphenhydramine and famotidine, requiring initiation of an epinephrine infusion. This caused further progression of QT prolongation, which precipitated recurrent polymorphic ventricular tachycardia (VT), with one implantable cardioverter defibrillator shock and two successful antitachycardia pacing (ATP) terminations. The R-on-T phenomenon was observed, which triggered polymorphic VT. Subsequently, ATP was unsuccessful, and resulted in an implantable cardioverter defibrillator shock that restored her sinus rhythm. She developed recurrent anaphylactic symptoms (throat tightening and predominantly hoarse voice) during an attempt to stop epinephrine infusion; hence, she was shifted to the tertiary care centre, and her device settings were changed. Subsequently, shortening of the QT interval was noted with no further significant events and epinephrine therapy was weaned.