Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Kidney failure; emergency dialysis; severe body ache unable to walk or move without assistance; bad chills; joint pain; muscle aches; sharp pain at the injection site; severe headache; 100-103 degree temperature; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (Kidney failure) and DIALYSIS (emergency dialysis) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Colitis (Have not been taking medications from 3-4 years). Concurrent medical conditions included Hypertension, Diabetes, Cholesterol high and Drug allergy (Allergic to NSAIDS). Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for Blood pressure high, METFORMIN for Diabetes, ATORVASTATIN for High cholesterol, ACETYLSALICYLIC ACID (BABY ASPIRIN) and MINERALS NOS, VITAMINS NOS (ONE A DAY ADVANCE ADULTS) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PAIN (sharp pain at the injection site), HEADACHE (severe headache), PYREXIA (100-103 degree temperature), ARTHRALGIA (joint pain) and MYALGIA (muscle aches). On 20-Feb-2021, the patient experienced CHILLS (bad chills). On 04-Mar-2021, the patient experienced GAIT DISTURBANCE (severe body ache unable to walk or move without assistance). On 06-Mar-2021, the patient experienced RENAL FAILURE (Kidney failure) (seriousness criterion hospitalization) and DIALYSIS (emergency dialysis) (seriousness criterion hospitalization). The patient was hospitalized from 05-Mar-2021 to 14-Mar-2021 due to DIALYSIS and RENAL FAILURE. On 24-Feb-2021, PYREXIA (100-103 degree temperature) and CHILLS (bad chills) outcome was unknown. At the time of the report, RENAL FAILURE (Kidney failure) and DIALYSIS (emergency dialysis) had resolved, GAIT DISTURBANCE (severe body ache unable to walk or move without assistance) had not resolved and VACCINATION SITE PAIN (sharp pain at the injection site), HEADACHE (severe headache), ARTHRALGIA (joint pain) and MYALGIA (muscle aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Blood test: high (High) WBC high Sedimentation  rate elevated. On 22-Feb-2021, SARS-CoV-2 test: negative (Negative) negative. On 27-Feb-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 27-Feb-2021, a flu test was performed and results were not provided. On 05-Mar-2021, blood work and CT scan were performed and results were not provided.  Treatment:   Mobic and Hydrocodone for pain on 22FEB2021                     Two Antibiotics and discontinue Mobic on 27FEB2021                     Emergency Dialysis on 06MAR2021                     IV Antibiotics and Steroids were given at hospital Patient was advised to follow up with Nephrologist and Rheumatologist.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Historical conditions added, Hypertension, Diabetes, High cholesterol, Colitis. Concomitant drugs added Lisinopril/HCTZ, Metformin, Atorvastatin, Baby aspirin and Men's one a day. The outcome of events changed to Recovered. The patient updated new adverse event as severe body aches unable to walk or move without assistance and was admitted to hospital and the outcome of the event is not recovered.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.