Age: 51.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: COVID-19, Haemorrhage, Pain
Clinical narrative: Bleeding; Generalized aching; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding) in a 51-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 products included non-company products ADALIMUMAB (HUMIRA) for Crohn's disease and IBUPROFEN for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form and IBUPROFEN (unknown route) 1 dosage form. In January 2022, the patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion medically significant), PAIN (Generalized aching) and COVID-19 (COVID-19). At the time of the report, HAEMORRHAGE (Bleeding) outcome was unknown and PAIN (Generalized aching) and COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  The patient experienced blood passing and body aches after taking vaccination. In 2022, the COVID resolved. On an unknown date, body aches after taking vaccination resolved. Ibuprofen and moderna COVID-19 vaccine (elasomeran) were also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Reporter provided causality of Bleeding, Generalized aching and COVID-19 with HUMIRA as not provided.  Reporter provided causality of Generalized aching and COVID-19 with IBUPROFEN as not provided and with Bleeding was probable.  No treatment information was reported by the reporter.  Company comment: This spontaneous case concerns a 51-year-old male patient, treated with co-suspect drugs Adalimumab indicated for moderate to severe adult Crohn's disease unknown (onset date of Adalimumab was not provided and no relevant medical history was reported) and Ibuprofen (indication unknown), who experienced the unexpected serious (medically significant) event of Haemorrhage and unexpected non-serious AESI COVID-19 that occurred after receiving the 1st dose of mRNA-1273 vaccine on an unknown date. Clinical course, laboratory tests and treatment details were not reported. The outcome of event haemorrhage was reported as unknown, and COVID-19 resolved. Co-suspect drugs Ibuprofen and Adalimumab indicated for moderate to severe adult Crohn's disease is suggestive of underlying Crohn's disease could be considered as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 51-year-old male patient, treated with co-suspect drugs Adalimumab indicated for moderate to severe adult Crohn's disease unknown (onset date of Adalimumab was not provided and no relevant medical history was reported) and Ibuprofen (indication unknown), who experienced the unexpected serious (medically significant) event of Haemorrhage and unexpected non-serious AESI COVID-19 that occurred after receiving the 1st dose of mRNA-1273 vaccine on an unknown date. Clinical course, laboratory tests and treatment details were not reported. The outcome of event haemorrhage was reported as unknown, and COVID-19 resolved. Co-suspect drugs Ibuprofen and Adalimumab indicated for moderate to severe adult Crohn's disease is suggestive of underlying Crohn's disease could be considered as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.