Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation reaction, Thrombosis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (BLOOD CLOTS IN RIGHT FOREARM/Thrombosis arm) in a 52-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis. Concurrent medical conditions included Venous insufficiency since 2011, Rheumatoid arthritis and Thrombosis leg. On 10-Jun-2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 14-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2022, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced THROMBOSIS (BLOOD CLOTS IN RIGHT FOREARM/Thrombosis arm) (seriousness criterion medically significant). In June 2021, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction) and ARTHRALGIA (Generalised joint pains/PAIN IN ALMOST ALL JOINTS INCLUDING KNEES, BUTTOCKS, ELBOWS AND FINGERS). At the time of the report, THROMBOSIS (BLOOD CLOTS IN RIGHT FOREARM/Thrombosis arm) and ARTHRALGIA (Generalised joint pains/PAIN IN ALMOST ALL JOINTS INCLUDING KNEES, BUTTOCKS, ELBOWS AND FINGERS) had not resolved and IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown. No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as Solution for injection in pre-filled syringe. The reporter causality for the events of Thrombosis arm, Generalised joint pains, Vaccination adverse reaction was Not related for co-suspect Humira. Primary reporter did not have the lot number information, because the packaging was discarded. 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 a female patient aged 52 years with relevant medical history of Peripheral venous disease and Thrombosis leg reported, who experienced the unexpected serious (medically significant) AESI event of Thrombosis (reported as BLOOD CLOTS IN RIGHT FOREARM/Thrombosis arm) on unknown dates in May 2021 after the first dose of mRNA-1273 vaccine. Patient had received initial two doses of mRNA-1273 approximately at an interval of one month and third dose seven months later. No further information on detailed clinical course, investigations, treatment of the event was available in the report.  Outcome of the event was not resolved at the time of report. Relevant medical history remains a confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement. Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns a female patient aged 52 years with relevant medical history of Peripheral venous disease and Thrombosis leg reported, who experienced the unexpected serious (medically significant) AESI event of Thrombosis (reported as BLOOD CLOTS IN RIGHT FOREARM/Thrombosis arm) on unknown dates in May 2021 after the first dose of mRNA-1273 vaccine. Patient had received initial two doses of mRNA-1273 approximately at an interval of one month and third dose seven months later. No further information on detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was not resolved at the time of report. Relevant medical history remains a confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.