Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Off label use, Syncope, Urticaria
Clinical narrative: Kidney was shutting down; fainted twice; Hives; 'the patient was told not to get another dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE KIDNEY INJURY (Kidney was shutting down), SYNCOPE (fainted twice) and URTICARIA (Hives) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced ACUTE KIDNEY INJURY (Kidney was shutting down) (seriousness criteria hospitalization and medically significant), SYNCOPE (fainted twice) (seriousness criteria hospitalization and medically significant) and URTICARIA (Hives) (seriousness criterion hospitalization). On an unknown date, the patient experienced OFF LABEL USE ('the patient was told not to get another dose of the vaccine). The patient was hospitalized from sometime in February 2021 to sometime in February 2021 due to ACUTE KIDNEY INJURY, SYNCOPE and URTICARIA. At the time of the report, ACUTE KIDNEY INJURY (Kidney was shutting down), SYNCOPE (fainted twice) and URTICARIA (Hives) outcome was unknown and OFF LABEL USE ('the patient was told not to get another dose of the vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   After the first dose of vaccination, on 06-Feb-2021, patient started having side effects. She had hives, her kidneys were shutting down and she fainted twice. She went to the hospital on 6th or 7th of  February 2021 were she was admitted for 3 days. She was not diagnosed because everything was new, but they told her not to get another dose of the vaccine.  Company Comment: This case concerns a 72-year-old, female patient with no relevant medical history, who experienced the unexpected events of acute kidney injury, syncope and urticaria, off label dosing frequency was considered as an additional event. The events occurred approximately 2 days after the first dose of Moderna COVID-19 Vaccine. The patient had hives, her kidneys were shutting down and she fainted twice. The patient was admitted to hospital for 3 days.The rechallenge was not applicable, as the events happened after the first dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 72-year-old, female patient with no relevant medical history, who experienced the unexpected events of acute kidney injury, syncope and urticaria, off label dosing frequency was considered as an additional event. The events occurred approximately 2 days after the first dose of Moderna COVID-19 Vaccine. The patient had hives, her kidneys were shutting down and she fainted twice. The patient was admitted to hospital for 3 days.The rechallenge was not applicable, as the events happened after the first dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.