Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Illness, Muscle spasms, Nausea
Clinical narrative: Nutrition is going down; Brain fog; Confused; Disoriented; Dehydrated, cannot got enough fluids in; Severe nausea; Severe vomiting; Renal function was affected; Very slurred speech; Severe muscle spasms; Lots of facial swelling; Inability to walk/ trouble walking; same symptoms/ sick; same symptoms/ fatigue; This spontaneous case was reported by a nurse and describes the occurrence of RENAL IMPAIRMENT (Renal function was affected) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 091021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer surgery. Concurrent medical conditions included Cancer (diagnosed with cancer in spring and had surgery) and Nephrectomy (she only has one kidney now). Concomitant products included LEVOTHYROXINE, PEMBROLIZUMAB (KEYTRUDA) and AXITINIB (INLYTA) for an unknown indication.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced RENAL IMPAIRMENT (Renal function was affected) (seriousness criterion medically significant), MUSCLE SPASMS (Severe muscle spasms), SWELLING FACE (Lots of facial swelling), GAIT DISTURBANCE (Inability to walk/ trouble walking), NUTRITIONAL CONDITION ABNORMAL (Nutrition is going down), FEELING ABNORMAL (Brain fog), CONFUSIONAL STATE (Confused), DISORIENTATION (Disoriented), DEHYDRATION (Dehydrated, cannot got enough fluids in), NAUSEA (Severe nausea) and VOMITING (Severe vomiting). 09-Sep-2021, the patient experienced DYSARTHRIA (Very slurred speech). In September 2021, the patient experienced ILLNESS (same symptoms/ sick) and FATIGUE (same symptoms/ fatigue). At the time of the report, RENAL IMPAIRMENT (Renal function was affected) and NUTRITIONAL CONDITION ABNORMAL (Nutrition is going down) had not resolved and DYSARTHRIA (Very slurred speech), MUSCLE SPASMS (Severe muscle spasms), SWELLING FACE (Lots of facial swelling), GAIT DISTURBANCE (Inability to walk/ trouble walking), ILLNESS (same symptoms/ sick), FEELING ABNORMAL (Brain fog), CONFUSIONAL STATE (Confused), DISORIENTATION (Disoriented), DEHYDRATION (Dehydrated, cannot got enough fluids in), NAUSEA (Severe nausea), VOMITING (Severe vomiting) and FATIGUE (same symptoms/ fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included immunotherapy for chemo. It was reported that the patient looked like having Bell's palsy and was never been like this before. She had to go to the ER 3 times to get IV therapy and visited the physician twice. Treatment information included IV therapy at ER 3 times.  Company Comment: This case concerns a 66-year-old, female patient with previous relevant medical history of Cancer and Nephrectomy, who experienced the unexpected event of Renal Impairment. The event occurred on the same day after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since the event of renal impairment happened only in the second dose. The rechallenge for the events of illness, nausea, vomiting, fatigue, and gait inability is not applicable since the outcome of the events from the first dose are unknown. The medical history of cancer and nephrectomy remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-335638 (Patient Link).; Sender's Comments: This case concerns a 66-year-old, female patient with previous relevant medical history of Cancer and Nephrectomy, who experienced the unexpected event of Renal Impairment. The event occurred on the same day after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since the event of renal impairment happened only in the second dose. The rechallenge for the events of illness, nausea, vomiting, fatigue, and gait inability is not applicable since the outcome of the events from the first dose are unknown. The medical history of cancer and nephrectomy remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.