Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Skin discolouration, Stress, Vaccination site erythema, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 65-year-old female 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 Rheumatoid arthritis, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and METHOTREXATE for an unknown indication. Concurrent medical conditions included Rheumatoid arthritis. On 29-Nov-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free. and METHOTREXATE (unknown route) at an unspecified dose. In 2021, the patient experienced JOINT SWELLING (MIDDLE JOINT ON FINGER WAS SORE AND SWOLLEN AND IT AFFECTED REST OF RIGHT HAND), FEELING ABNORMAL (FELT OUT OF SORTS/FELT LIFELESS AFTER COVID VACCINATION), RASH MACULAR (BROWN SPOTS UNDERNEATH THE RED RASH/ARMS BLOCHTY) and HEADACHE (Headache). On 15-Nov-2021, the patient experienced ARTHRALGIA (FEELING SHOULDER PAIN). In January 2022, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). On an unknown date, the patient experienced OCULAR DISCOMFORT (EYES BOTHERING), SKIN DISCOLOURATION (MOLE ON ARM GOT DARKER), INFLAMMATION (INFLAMMATION THAT PRESENTS AS REDNESS THAT MOVED FROM PLACE TO PLACE ON BODY), DISCOMFORT (Discomfort), FEELING COLD (Coldness), CONTUSION (TUMMY AREA BRUISING), STRESS (ACHINESS/PAIN AND ATTRIBUTES IT TO STRESS), RASH ERYTHEMATOUS (RASH WENT AND CAME/RED RASH ON HANDS, ARMS AND THE BACK OF HEAD/Red rash on arms), PERIPHERAL SWELLING (ARM/RIGHT HAND SWOLLEN AFTER COVID VACCINATION), ERYTHEMA (ARMS RED/TUMMY AREA GOT REDNESS), PAIN IN EXTREMITY (ARM ACHE AFTER SECOND COVID VACCINE/), FATIGUE (Tiredness / FATIGUE AFTER VACCINATIONS), VACCINATION SITE RASH (Vaccination site rash/RED RASH ON ARM AFTER VACCINE) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). In 2021, HEADACHE (Headache) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), INFLAMMATION (INFLAMMATION THAT PRESENTS AS REDNESS THAT MOVED FROM PLACE TO PLACE ON BODY), CONTUSION (TUMMY AREA BRUISING), FEELING ABNORMAL (FELT OUT OF SORTS/FELT LIFELESS AFTER COVID VACCINATION) and RASH MACULAR (BROWN SPOTS UNDERNEATH THE RED RASH/ARMS BLOCHTY) outcome was unknown, OCULAR DISCOMFORT (EYES BOTHERING), SKIN DISCOLOURATION (MOLE ON ARM GOT DARKER), DISCOMFORT (Discomfort), FEELING COLD (Coldness), JOINT SWELLING (MIDDLE JOINT ON FINGER WAS SORE AND SWOLLEN AND IT AFFECTED REST OF RIGHT HAND), STRESS (ACHINESS/PAIN AND ATTRIBUTES IT TO STRESS), RASH ERYTHEMATOUS (RASH WENT AND CAME/RED RASH ON HANDS, ARMS AND THE BACK OF HEAD/Red rash on arms), ARTHRALGIA (FEELING SHOULDER PAIN) and PAIN IN EXTREMITY (ARM ACHE AFTER SECOND COVID VACCINE/) had not resolved and PERIPHERAL SWELLING (ARM/RIGHT HAND SWOLLEN AFTER COVID VACCINATION), ERYTHEMA (ARMS RED/TUMMY AREA GOT REDNESS), FATIGUE (Tiredness / FATIGUE AFTER VACCINATIONS), VACCINATION SITE RASH (Vaccination site rash/RED RASH ON ARM AFTER VACCINE) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant information was provided. This case was identified as a part of a retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation Private. Company comment: This spontaneous case concerns a female patient aged 65 years with reported concurrent condition of rheumatoid arthritis on Humira, experienced unexpected serious (medically significant) AESI event of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up in Jan.2022) on unknown dates in the context of mRNA-1273 vaccination. Patient had received initial two doses of same vaccine on unknown dates and booster dose of Tozinameran approximately two months prior to the event. Patient also experienced multiple non-serious events of ocular discomfort, Arthralgia, Stress, Rash macular, Rash erythematous Peripheral swelling. No further information on detailed clinical course, investigations and treatment received was available in the report. Outcome of the event Rheumatoid arthritis flare up was not known at the time of report. Relevant concurrent condition of rheumatoid arthritis remains a confounder to the event Rheumatoid arthritis flare up. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement. Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2022: Significant follow up received. Events(tiredness and fatigue ) added. Events verbatim updated. subsume Event Pain under stress, subsume Event Melanocytic nevus under Skin discolouration and subsume Rash macular (ARMS BLOCHTY) under Rash macular (BROWN SPOTS UNDERNEATH THE RED RASH). Sender's Comments: This spontaneous case concerns a female patient aged 65 years with reported concurrent condition of rheumatoid arthritis on Humira, experienced unexpected serious (medically significant) AESI event of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up in Jan.2022) on unknown dates in the context of mRNA-1273 vaccination. Patient had received initial two doses of same vaccine on unknown dates and booster dose of Tozinameran approximately two months prior to the event. Patient also experienced multiple non-serious events of ocular discomfort, Arthralgia, Stress, Rash macular, Rash erythematous Peripheral swelling. No further information on detailed clinical course, investigations and treatment received was available in the report.  Outcome of the event Rheumatoid arthritis flare up was not known at the time of report. Relevant concurrent condition of rheumatoid arthritis remains a confounder to the event Rheumatoid arthritis flare up. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.