Sex: F
Vaccine: COVID19
Symptoms: Abscess limb, Pneumonia
Clinical narrative: Abscess on left foot; Pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of ABSCESS LIMB (Abscess on left foot) and PNEUMONIA (Pneumonia) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 4782591) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ABSCESS LIMB (Abscess on left foot) (seriousness criterion medically significant) and PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, ABSCESS LIMB (Abscess on left foot) and PNEUMONIA (Pneumonia) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication was provided.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  The reporter causality for the events of abscess on left foot and Pneumonia with Moderna COVID-19-Vaccine was assessed as related.  Company comment:  This spontaneous case report concerns an elderly female patient with medical history of Rheumatoid arthritis on therapy with adalimumab, who experienced serious (medically significant) unexpected events of Pneumonia and Abscess limb after receiving mRNA-1273 vaccine. Dose of the vaccine, as well as vaccination date and start dates of the reported events were not provided, therefore, the temporal relationship cannot be determined. At the time of this report, the events were resolving, however, no further details regarding clinical course of the events or treatment medications were provided. Co-suspect medication adalimumab is considered as a significant confounding factor, taking into consideration that it is known that patients on adalimumab therapy have an increased risk for developing various infections, even serious or fatal infections. No further details were available for medical assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case report concerns an elderly female patient with medical history of Rheumatoid arthritis on therapy with adalimumab, who experienced serious (medically significant) unexpected events of Pneumonia and Abscess limb after receiving mRNA-1273 vaccine. Dose of the vaccine, as well as vaccination date and start dates of the reported events were not provided, therefore, the temporal relationship cannot be determined. At the time of this report, the events were resolving, however, no further details regarding clinical course of the events or treatment medications were provided. Co-suspect medication adalimumab is considered as a significant confounding factor, taking into consideration that it is known that patients on adalimumab therapy have an increased risk for developing various infections, even serious or fatal infections. No further details were available for medical assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.