Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Inappropriate schedule of product administration, Oropharyngeal pain, Pneumonia
Clinical narrative: diagnosed with pneumonia; labwork was pointing toward kidney failure; the patient received their 2 doses on 1st dose received on 15Feb2021 and 20thApr2021; Sore arm; fever 103; bronchitis; sore throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (diagnosed with pneumonia) and RENAL FAILURE (labwork was pointing toward kidney failure) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diabetes since an unknown date. Concomitant products included INSULIN LISPRO (HUMALOG), METFORMIN, LOSARTAN, SIMVASTATIN and CHLORTHALIDONE.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). On 07-Mar-2021, the patient experienced BRONCHITIS (bronchitis) and PYREXIA (fever 103). On an unknown date, the patient experienced PNEUMONIA (diagnosed with pneumonia) (seriousness criteria hospitalization and medically significant), RENAL FAILURE (labwork was pointing toward kidney failure) (seriousness criteria hospitalization and medically significant), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the patient received their 2 doses on 1st dose received on 15Feb2021 and 20thApr2021) and VACCINATION SITE PAIN (Sore arm). The patient was hospitalized from 17-Mar-2021 to 21-Mar-2021 due to RENAL FAILURE. At the time of the report, PNEUMONIA (diagnosed with pneumonia), RENAL FAILURE (labwork was pointing toward kidney failure), BRONCHITIS (bronchitis), OROPHARYNGEAL PAIN (sore throat), VACCINATION SITE PAIN (Sore arm) and PYREXIA (fever 103) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the patient received their 2 doses on 1st dose received on 15Feb2021 and 20thApr2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, COVID-19 (negative-positive): negative (Negative) Negative. On 07-Mar-2021, Pyrexia: 103 (High) Fever 103.         Treatment reported by the patient included antibiotics after the emergency room visit, and Levofloxacin treatment for 17 days after the hospitalization.  Based on the current available information an association between the use of the product and the events cannot be excluded.  This report also refers to an event of inappropriate schedule of vaccine administration.  There were no AEs specifically associated with this medication error   This case was linked to US-MODERNATX, INC.-MOD-2021-089307 (E2B Linked Report).; Sender's Comments: Based on the current available information an association between the use of the product and the events cannot be excluded.  This report also refers to an event of inappropriate schedule of vaccine administration.  There were no AEs specifically associated with this medication error US-MODERNATX, INC.-MOD-2021-089307: