Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Renal failure, SARS-CoV-2 test
Clinical narrative: Patient was hospitalized as the Covid-19 was so severe; she has kidney failure; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient was hospitalized as the Covid-19 was so severe) and RENAL FAILURE (she has kidney failure) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Aug-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In January 2022, the patient experienced COVID-19 (Patient was hospitalized as the Covid-19 was so severe) (seriousness criterion hospitalization). On an unknown date, the patient experienced RENAL FAILURE (she has kidney failure) (seriousness criterion medically significant). The patient was hospitalized on sometime in 2022 due to COVID-19. On 22-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, COVID-19 (Patient was hospitalized as the Covid-19 was so severe) and RENAL FAILURE (she has kidney failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: positive (Positive) Tested Positive.         No concomitant medications were reported.  The patient received both the doses of Moderna Covid-19 vaccine in her left arm shoulder deltoid muscle as an intramuscular injection and the patient reports no adverse reactions or side effects after both the doses of Moderna Covid-19 vaccine.   The patient received her booster dose as the Pfizer vaccine in her left arm shoulder deltoid muscle. The patient reports no Adverse reactions or side effects to the booster dose.   It was reported that In January of 2022, the patient got Covid-19 and was sick for a long time. The patient says that she has kidney failure and that she wants to receive a Moderna Covid-19 vaccine for her fourth booster dose. The patient tested positive for Covid-19 in January 2022.  Patient had a sore throat on 06-Jan-2022. Patient was hospitalized as the Covid-19 was so severe. Patient still has phlegm in her chest from the Covid-19.  No treatment details were reported.  Company comment: This is a spontaneous case concerning an 80 year-old, female patient with no reported medical history, who experienced the serious (due to hospitalization) unexpected, AESI of COVID-19 and the serious (due to medically important condition) unexpected, AESI of Renal failure. The event COVID-19 occurred approximately 1 year after the second dose of mRNA-1273 vaccine and the event renal failure on an unknown date. Additionally, Inappropriate schedule of product administration (interval between first and second dose was 24 days) was reported in this case. The patient received a booster dose of COVID-19 vaccine Tozinameran approximately 7 months after primary series with mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-512983, MOD-2022-512983.; Sender's Comments: This is a spontaneous case concerning an 80 year-old, female patient with no reported medical history, who experienced the serious (due to hospitalization) unexpected, AESI of COVID-19 and the serious (due to medically important condition) unexpected, AESI of Renal failure. The event COVID-19 occurred approximately 1 year after the second dose of mRNA-1273 vaccine and the event renal failure on an unknown date. Additionally, Inappropriate schedule of product administration (interval between first and second dose was 24 days) was reported in this case. The patient received a booster dose of COVID-19 vaccine Tozinameran approximately 7 months after primary series with mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.