Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Gastric disorder, Haemorrhage, Helicobacter infection, Skin discolouration
Clinical narrative: Brown skinned face / Face turning black; Helicobacter pylori infection; Stomach issues; Bleeding; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding) in a 64-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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-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) at an unspecified dose. In March 2021, the patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion medically significant). On an unknown date, the patient experienced SKIN DISCOLOURATION (Brown skinned face / Face turning black), HELICOBACTER INFECTION (Helicobacter pylori infection) and GASTRIC DISORDER (Stomach issues). At the time of the report, HAEMORRHAGE (Bleeding), SKIN DISCOLOURATION (Brown skinned face / Face turning black), HELICOBACTER INFECTION (Helicobacter pylori infection) and GASTRIC DISORDER (Stomach issues) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  On unknown dates, patient experienced skin brown and face turning black. Had helicobacter pylori and stomach issues as well. In 2021, patient experienced a lot of health issues. In March 2021, patient reported bleeding and a reaction after COVID-19 vaccine.  Formulation for Humira is reported as Solution for injection in pre-filled pen.  Causality for Humira(adalimumab): The reporter's causality for the event(s) of brown skinned/face turning black, bleeding, helicobacter pylori, stomach issues, reaction after covid-19 vaccine and lot of unspecified issues was not provided.    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 64-year-old, male patient with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced an unexpected, medically significant event of Haemorrhage in association with a dose of mRNA-1273 vaccine. Patient received a 2-dose primary series of mRNA-1273 vaccine, given 29 days apart. The event bleeding occurred within the same month of vaccination with a 2nd dose of mRNA-1273 vaccine. Patient also reported Helicobacter pylori and stomach issues on unknown dates. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying rheumatoid arthritis and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns a 64-year-old, male patient with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced an unexpected, medically significant event of Haemorrhage in association with a dose of mRNA-1273 vaccine. Patient received a 2-dose primary series of mRNA-1273 vaccine, given 29 days apart. The event bleeding occurred within the same month of vaccination with a 2nd dose of mRNA-1273 vaccine. Patient also reported Helicobacter pylori and stomach issues on unknown dates. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying rheumatoid arthritis and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.