Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Organ failure, Product dose omission issue, Pruritus, Rash
Clinical narrative: Stage four kidney failure; organ shutting down; Dress syndrome; leiomyosarcoma; loss of appetite; itching; Patient is very sick since 1 dose; Did not received 2 dose; rash that went from her neck, chest, abdomen, and upper thighs; very fatigued; felt throat was closing up; very thirsty; she "started not feeling well"; This spontaneous case was reported by a consumer and describes the occurrence of DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Dress syndrome), LEIOMYOSARCOMA (leiomyosarcoma), RENAL FAILURE (Stage four kidney failure) and ORGAN FAILURE (organ shutting down) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood cholesterol increased. Concurrent medical conditions included Blood pressure high, Immune disorder (NOS) and Osteoarthritis. Concomitant products included ATENOLOL and LEVOTHYROXINE for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced MALAISE (she "started not feeling well"), THIRST (very thirsty), THROAT TIGHTNESS (felt throat was closing up), RASH (rash that went from her neck, chest, abdomen, and upper thighs) and FATIGUE (very fatigued). On an unknown date, the patient experienced DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Dress syndrome) (seriousness criterion medically significant), LEIOMYOSARCOMA (leiomyosarcoma) (seriousness criterion medically significant), RENAL FAILURE (Stage four kidney failure) (seriousness criteria hospitalization and medically significant), ORGAN FAILURE (organ shutting down) (seriousness criterion hospitalization), DECREASED APPETITE (loss of appetite), PRURITUS (itching), ILLNESS (Patient is very sick since 1 dose) and PRODUCT DOSE OMISSION ISSUE (Did not received 2 dose). The patient was treated with PREDNISONE at a dose of 60 mg. At the time of the report, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Dress syndrome), LEIOMYOSARCOMA (leiomyosarcoma), RENAL FAILURE (Stage four kidney failure), ORGAN FAILURE (organ shutting down), MALAISE (she "started not feeling well"), DECREASED APPETITE (loss of appetite), THIRST (very thirsty), THROAT TIGHTNESS (felt throat was closing up), ILLNESS (Patient is very sick since 1 dose), PRODUCT DOSE OMISSION ISSUE (Did not received 2 dose) and FATIGUE (very fatigued) outcome was unknown and PRURITUS (itching) and RASH (rash that went from her neck, chest, abdomen, and upper thighs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.  However, very limited information is available regarding concomitant diseases and medications that could be confounders for the events. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: A Followup received on 25 May2021 has information on Newadverse events and concomitant medications were added. Contact information was updated.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.  However, very limited information is available regarding concomitant diseases and medications that could be confounders for the events. Further information has been requested.