Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cold sweat, Gait inability, Muscular weakness
Clinical narrative: Rash from his waist up to his neck and down to his arms; Muscle weakness; COULD NOT WALK; COLD BUT SWEATING; cold chills and hot chills; fever; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash from his waist up to his neck and down to his arms), MUSCULAR WEAKNESS (Muscle weakness), GAIT INABILITY (COULD NOT WALK), COLD SWEAT (COLD BUT SWEATING), CHILLS (cold chills and hot chills) and PYREXIA (fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced RASH (Rash from his waist up to his neck and down to his arms) (seriousness criterion hospitalization), MUSCULAR WEAKNESS (Muscle weakness) (seriousness criterion hospitalization), GAIT INABILITY (COULD NOT WALK) (seriousness criterion hospitalization), COLD SWEAT (COLD BUT SWEATING) (seriousness criterion hospitalization), CHILLS (cold chills and hot chills) (seriousness criterion hospitalization) and PYREXIA (fever) (seriousness criterion hospitalization). The patient was hospitalized on 05-Apr-2021 due to CHILLS, COLD SWEAT, GAIT INABILITY, MUSCULAR WEAKNESS, PYREXIA and RASH. At the time of the report, RASH (Rash from his waist up to his neck and down to his arms), MUSCULAR WEAKNESS (Muscle weakness), GAIT INABILITY (COULD NOT WALK), COLD SWEAT (COLD BUT SWEATING), CHILLS (cold chills and hot chills) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.         Concomitant drugs were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of  COLD BUT SWEATING, COULD NOT WALK and MUSCLE WEAKNESS with SKYRIZI was not provided.   The reporter's causality for the event of COVID with SKYRIZI was a reasonable possibility.   The opinion is that there is no reasonable possibility that the events of  COVID, COLD BUT SWEATING, COULD NOT WALK and MUSCLE WEAKNESS are related to SKYRIZI.  Treatment details were not given.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This spontaneous case concerns a 65-year-old, male patient with history of co-suspect administration of Skyrizi (risankizumab) for Moderate-to-severe Chronic Plaque Psoriasis, who experienced the unexpected, serious (hospitalization) events of rash, muscular weakness, gait inability, cold sweat, chills and pyrexia. The events occurred unknown number of days after receiving the first dose of the mRNA-1273 vaccine. It was reported that the patient was hospitalized on the same day after receiving the first dose of the mRNA-1273 vaccine. The patient broke out in a rash from his waist up to his neck and down to his arms. His muscles were weak and he could not walk. He had cold chills and hot chills with a fever of 101. He had muscle weakness and he was cold but sweating. No further clinical information (including details about hospitalization, laboratory test/s, clinical course and treatment) was available for medical review. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 65-year-old, male patient with history of co-suspect administration of Skyrizi (risankizumab) for Moderate-to-severe Chronic Plaque Psoriasis, who experienced the unexpected, serious (hospitalization) events of rash, muscular weakness, gait inability, cold sweat, chills and pyrexia. The events occurred unknown number of days after receiving the first dose of the mRNA-1273 vaccine. It was reported that the patient was hospitalized on the same day after receiving the first dose of the mRNA-1273 vaccine. The patient broke out in a rash from his waist up to his neck and down to his arms. His muscles were weak and he could not walk. He had cold chills and hot chills with a fever of 101. He had muscle weakness and he was cold but sweating. No further clinical information (including details about hospitalization, laboratory test/s, clinical course and treatment) was available for medical review. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.