Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Thrombosis
Clinical narrative: Arthritis aggravated; Clot blood; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis aggravated) and THROMBOSIS (Clot blood) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    Concurrent medical conditions included Clot blood.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2022, received third 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. On an unknown date, the patient experienced ARTHRITIS (Arthritis aggravated) (seriousness criterion hospitalization) and THROMBOSIS (Clot blood) (seriousness criteria hospitalization and medically significant). At the time of the report, ARTHRITIS (Arthritis aggravated) and THROMBOSIS (Clot blood) had resolved.            No concomitant medications were reported.  Patient took COVID-19 vaccine in last two years and was admitted to hospital and nursing due to bad response. The COVID-19 vaccine hit her immune system and made arthritis worse. There was a history of blood clots and had one due to COVID vaccine.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter causality IMMUNE SYSTEM DISORDER (Immune system disorder/Bad response due to COVID-19 vaccine/hit immune system), and THROMBOSIS (Clot blood) were as not related and for event Arthritis aggravated was not reported with Humira  No treatment medications were reported.  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 an elderly female patient of unknown age with medical history of thrombosis, who experienced the unexpected, serious (hospitalization) events of thrombosis (AESI) and arthritis (AESI) an unknown time after the third dose of mRNA-1273. The patient reports that the vaccine hit her immune system and made her arthritis worse. The medical history of thrombosis, as well as co-suspect medication adalimumab, are confounders for both events. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly female patient of unknown age with medical history of thrombosis, who experienced the unexpected, serious (hospitalization) events of thrombosis (AESI) and arthritis (AESI) an unknown time after the third dose of mRNA-1273. The patient reports that the vaccine hit her immune system and made her arthritis worse. The medical history of thrombosis, as well as co-suspect medication adalimumab, are confounders for both events. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.