Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Inclusion body myositis, Psoriasis, Vaccination site pain
Clinical narrative: Muscle disease sporadic inclusion body myositis; Plaque psoriasis flare up under left arm; Vaccine dose 1 received on 20-Mar-2021 and dose 2 received on 01-Apr-2021; Sore arm after Moderna vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INCLUSION BODY MYOSITIS (Muscle disease sporadic inclusion body myositis) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-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 ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 01-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine dose 1 received on 20-Mar-2021 and dose 2 received on 01-Apr-2021). In 2021, the patient experienced VACCINATION SITE PAIN (Sore arm after Moderna vaccination). On an unknown date, the patient experienced INCLUSION BODY MYOSITIS (Muscle disease sporadic inclusion body myositis) (seriousness criterion medically significant) and PSORIASIS (Plaque psoriasis flare up under left arm). At the time of the report, INCLUSION BODY MYOSITIS (Muscle disease sporadic inclusion body myositis) and PSORIASIS (Plaque psoriasis flare up under left arm) had not resolved and VACCINATION SITE PAIN (Sore arm after Moderna vaccination) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine dose 1 received on 20-Mar-2021 and dose 2 received on 01-Apr-2021) outcome was unknown.            No concomitant medications were reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event(s) of sore arm after Moderna vaccination and muscle disease sporadic inclusion body myositis with Humira(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of plaque psoriasis flare up under left arm with Humira (adalimumab) was a reasonable possibility. The reporter's causality for sore arm after Moderna vaccination with Moderna Covid-19 vaccine was reported as possible.  No treatment details were reported. Company comment-This spontaneous case concerns a male patient aged 79 years with no relevant medical history experienced unexpected serious (medically significant) event of Inclusion body myositis on unknown date in the context of mRNA-1273 vaccination. Patient had received initial two doses of vaccination with mRNA-1273 at an interval of 12 days, so Inappropriate schedule of product administration was noted. No further information on detailed clinical course, investigations, treatment of the event was available in the report.  Outcome of the event was not recovered at the time of report.. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a male patient aged 79 years with no relevant medical history experienced unexpected serious (medically significant) event of Inclusion body myositis on unknown date in the context of mRNA-1273 vaccination. Patient had received initial two doses of vaccination with mRNA-1273 at an interval of 12 days, so Inappropriate schedule of product administration was noted. No further information on detailed clinical course, investigations, treatment of the event was available in the report.  Outcome of the event was not recovered at the time of report.. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.