Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary mass, Renal failure, Vaccination complication, Vasculitis
Clinical narrative: GPA or Wegner's disease; nodules in his lung; Fluid in his lungs; Pain in different parts of his body; Pain in legs & thighs; Vasculitis; stroke; stroke; stroke; Diagnosed with renal failure; Pale; Reaction to vaccine; On 2Apr2021 he went to the vaccine facility and was so pale, that they recommended that he wait a couple of weeks before getting his second shot; plasmapheresis; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (Diagnosed with renal failure), the first episode of CEREBROVASCULAR ACCIDENT (stroke), PAIN (Pain in different parts of his body), PAIN IN EXTREMITY (Pain in legs & thighs), PALLOR (Pale), VACCINATION COMPLICATION (Reaction to vaccine), VASCULITIS (Vasculitis), the second episode of CEREBROVASCULAR ACCIDENT (stroke), the third episode of CEREBROVASCULAR ACCIDENT (stroke), GRANULOMATOSIS WITH POLYANGIITIS (GPA or Wegner's disease), PULMONARY MASS (nodules in his lung), PLEURAL EFFUSION (Fluid in his lungs) and PLASMAPHERESIS (plasmapheresis) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sudden hearing loss since December 2020 and Bell's palsy since January 2021. Concomitant products included METOPROLOL and ATORVASTATIN for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION COMPLICATION (Reaction to vaccine) (seriousness criterion hospitalization). On 02-Apr-2021, the patient experienced PALLOR (Pale) (seriousness criterion hospitalization). On 07-Apr-2021, the patient experienced RENAL FAILURE (Diagnosed with renal failure) (seriousness criteria hospitalization and medically significant), PULMONARY MASS (nodules in his lung) (seriousness criterion hospitalization) and PLEURAL EFFUSION (Fluid in his lungs) (seriousness criterion hospitalization). On 12-Apr-2021, the patient experienced GRANULOMATOSIS WITH POLYANGIITIS (GPA or Wegner's disease) (seriousness criteria hospitalization and medically significant). On 16-Apr-2021, the patient experienced PLASMAPHERESIS (plasmapheresis) (seriousness criterion hospitalization prolonged). On 06-May-2021, the patient experienced the first episode of CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant), the second episode of CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant) and the third episode of CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PAIN (Pain in different parts of his body) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Pain in legs & thighs) (seriousness criterion hospitalization), OFF LABEL USE (On 2Apr2021 he went to the vaccine facility and was so pale, that they recommended that he wait a couple of weeks before getting his second shot) and VASCULITIS (Vasculitis) (seriousness criterion hospitalization). The patient was hospitalized from 07-Apr-2021 to 27-Apr-2021 due to CEREBROVASCULAR ACCIDENT, PAIN, PAIN IN EXTREMITY, PALLOR, RENAL FAILURE, VACCINATION COMPLICATION and VASCULITIS. The patient was treated with RITUXIMAB on 16-Apr-2021 for Vasculitis, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, RENAL FAILURE (Diagnosed with renal failure), PAIN (Pain in different parts of his body), PAIN IN EXTREMITY (Pain in legs & thighs), PALLOR (Pale), VACCINATION COMPLICATION (Reaction to vaccine), VASCULITIS (Vasculitis), the last episode of CEREBROVASCULAR ACCIDENT (stroke), GRANULOMATOSIS WITH POLYANGIITIS (GPA or Wegner's disease), PULMONARY MASS (nodules in his lung), PLEURAL EFFUSION (Fluid in his lungs) and PLASMAPHERESIS (plasmapheresis) outcome was unknown and OFF LABEL USE (On 2Apr2021 he went to the vaccine facility and was so pale, that they recommended that he wait a couple of weeks before getting his second shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Chest X-ray: abnormal (abnormal) Showed fluid & nodules in his lungs.. On 12-Apr-2021, Biopsy kidney: abnormal (abnormal) GPA or Wegner's disease or vasculitis.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 29-Mar-2021 got bloodwork done, and it was stated off on a couple of things. On 02-Apr-2021, the patient went to the vaccine facility to get 2nd shot of vaccine they recommended to wait for couple of weeks before getting next dose because and was looking pale. The patient received 2 blood transfusions, 5 plasmapheresis treatment. The patient discharged on 23-Apr-2021 and got readmitted to the hospital on 24-Apr-2021 and discharged on 27-Apr-2021.  Company comment: Based on the current available information; although the use of the product and the start date of the events were more than 2 months apart, a causal relationship cannot be excluded. For the event off label use, causality is not applicable.; Sender's Comments: Based on the current available information; although the use of the product and the start date of the events were more than 2 months apart, a causal relationship cannot be excluded. For the event off label use, causality is not applicable.