Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
Unexpected immunological response; This spontaneous case was reported by a patient and describes the occurrence of IMMUNE-MEDIATED ADVERSE REACTION (Unexpected immunological response) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Kidney transplant (First kidney transplant. Currently being evaluated for a second transplant). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNE-MEDIATED ADVERSE REACTION (Unexpected immunological response) (seriousness criterion medically significant). At the time of the report, IMMUNE-MEDIATED ADVERSE REACTION (Unexpected immunological response) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Complement analysis: Positive. On an unknown date, Flow cytometry: Positive. Concomitant medication was not reported. Patient had received three doses of Moderna Covid-19 vaccine. After vaccination, CDC (Complement-Dependent Cytotoxicity) and Flow Crossmatch tests returned positive results. The patient had been evaluated for 2nd kidney transplant, but this unexpected immunological response had raised serious concerns and significantly impacted patient's health and quality of life. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.; Reporter's Comments: Past medical history of Kidney transplant is a confounder for the event. The benefit -risk relationship of product is not affected by this report.
Medical History/Concurrent Conditions: Kidney transplant (First kidney transplant. Currently being evaluated for a second transplant)
Test Name: CDC (Complement-Dependent Cytotoxicity) and Flow Crossmatch tests; Test Result: Positive ; Test Name: Flow Crossmatch tests; Test Result: Positive