Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haematuria, Pain in extremity, Pyrexia, Transurethral prostatectomy
Clinical narrative: Patient also had a hospital admission for a TURP procedure; gross hematuria; sore arm; low-grade fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (low-grade fever), HAEMATURIA (gross hematuria) and TRANSURETHRAL PROSTATECTOMY (Patient also had a hospital admission for a TURP procedure) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A and 031H21A) for COVID-19 prophylaxis.     The patient's past medical history included Stent placement (heart stent put in) on 13-Jan-2022. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) from 13-Jan-2022 to an unknown date for Stent placement.   On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2022, the patient experienced PAIN IN EXTREMITY (sore arm) (seriousness criterion hospitalization) and PYREXIA (low-grade fever) (seriousness criterion hospitalization). On 22-Apr-2022, the patient experienced HAEMATURIA (gross hematuria) (seriousness criterion hospitalization). On an unknown date, the patient experienced TRANSURETHRAL PROSTATECTOMY (Patient also had a hospital admission for a TURP procedure) (seriousness criterion hospitalization). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (low-grade fever), HAEMATURIA (gross hematuria) and TRANSURETHRAL PROSTATECTOMY (Patient also had a hospital admission for a TURP procedure) outcome was unknown.            It was reported that the patient had received all Moderna shots. The patient received the first booster dose of Moderna Covid-19 vaccine on 15-Nov-2021. The patient received the second booster dose of Moderna Covid-19 vaccine on 15-Apr-2022.  The patient was doing some entertainment and some lifting when the event of hematuria had happened. Over a 4 month period, the patient was admitted to the hospital 7 times.  No treatment medication was reported.   This case was linked to MOD-2022-662512 (Patient Link).  Company Comment: This spontaneous case concerns a 68-year-old, male patient with history of Cardiac Stent placement (Jan2022) and concomitant intake of Plavix (clopidogrel), who experienced the unexpected, serious (hospitalization) events of pain in extremity (painful arm), pyrexia, haematuria (gross hematuria) and transurethral prostatectomy. The events pain in extremity, pyrexia and haematuria occurred beginning on the same day and up to 7 days after receiving the second booster dose of the mRNA-1273 original vaccine. The start date of the event transurethral prostatectomy was not provided, hence, the onset latency could not be assessed. Of note, the patient received the first booster dose of the mRNA-1273 original vaccine 5 months before receiving the second booster dose. After receiving the first booster dose, the patient had a sore arm and low-grade fever. No further details were provided. Almost 2 months after receiving the first booster dose, the patient had a Cardiac Stent placement (unknown indication) and was started on Plavix (unspecified dose, frequency and duration). No further details were provided. On the same day after receiving the second booster dose, the patient again experienced a sore arm and low-grade fever (body temperature measurement was not provided). Treatment information was not provided. The outcomes of these events were unknown at the time of the report. Seven days after receiving the second booster dose, the patient experienced gross hematuria which occurred while he was doing 'some entertainment' and 'some lifting'. It was reported that over a 4-month period, the patient was admitted seven times. This included a hospital admission for a Transurethral resection of the prostate (TURP) procedure. No further clinical information (including details about the said hospitalizations, diagnostic test/s, diagnosis and other treatment) was available for medical review. The concomitant intake of Plavix may be a risk factor for the event haematuria since hemorrhage is a common side effect of the medication. The benefit-risk relationship of the mRNA-1273 original vaccine is not affected by this report. Further information has been requested.; Sender's Comments: This spontaneous case concerns a 68-year-old, male patient with history of Cardiac Stent placement (Jan2022) and concomitant intake of Plavix (clopidogrel), who experienced the unexpected, serious (hospitalization) events of pain in extremity (painful arm), pyrexia, haematuria (gross hematuria) and transurethral prostatectomy. The events pain in extremity, pyrexia and haematuria occurred beginning on the same day and up to 7 days after receiving the second booster dose of the mRNA-1273 original vaccine. The start date of the event transurethral prostatectomy was not provided, hence, the onset latency could not be assessed. Of note, the patient received the first booster dose of the mRNA-1273 original vaccine 5 months before receiving the second booster dose. After receiving the first booster dose, the patient had a sore arm and low-grade fever. No further details were provided. Almost 2 months after receiving the first booster dose, the patient had a Cardiac Stent placement (unknown indication) and was started on Plavix (unspecified dose, frequency and duration). No further details were provided. On the same day after receiving the second booster dose, the patient again experienced a sore arm and low-grade fever (body temperature measurement was not provided). Treatment information was not provided. The outcomes of these events were unknown at the time of the report. Seven days after receiving the second booster dose, the patient experienced gross hematuria which occurred while he was doing 'some entertainment' and 'some lifting'. It was reported that over a 4-month period, the patient was admitted seven times. This included a hospital admission for a Transurethral resection of the prostate (TURP) procedure. No further clinical information (including details about the said hospitalizations, diagnostic test/s, diagnosis and other treatment) was available for medical review. The concomitant intake of Plavix may be a risk factor for the event haematuria since hemorrhage is a common side effect of the medication. The benefit-risk relationship of the mRNA-1273 original vaccine is not affected by this report. Further information has been requested.