Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Post procedural complication, Rheumatoid arthritis, Rotator cuff syndrome, Skin mass
Clinical narrative: possible rotator cuff issue; possible mole issue; Rheumatoid arthritis flare up; crohn's disease flare up; central nervous system was blown; flare up in heart; heart valve did not close properly; nodules underneath skin tissue; bad reaction to suture; bad reaction to rotator cuff surgery; could not swallow; Shingles; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ROTATOR CUFF SYNDROME (possible rotator cuff issue), MELANOCYTIC NAEVUS (possible mole issue), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and CROHN'S DISEASE (crohn's disease flare up) in an elderly 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 Crohn's disease and Rheumatoid arthritis, PREDNISONE for an unknown indication and HYDROXYCHLOROQUINE for an unknown indication.    Concurrent medical conditions included Crohn's disease and Rheumatoid arthritis. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   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) Solution for injection in pre-filled pen, Citrate free, PREDNISONE (unknown route) at an unspecified dose and HYDROXYCHLOROQUINE (unknown route) at an unspecified dose. On an unknown date, the patient experienced ROTATOR CUFF SYNDROME (possible rotator cuff issue) (seriousness criterion medically significant), MELANOCYTIC NAEVUS (possible mole issue) (seriousness criterion medically significant), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), CROHN'S DISEASE (crohn's disease flare up) (seriousness criterion medically significant), NERVOUS SYSTEM DISORDER (central nervous system was blown), CARDIAC DISORDER (flare up in heart), HEART VALVE INCOMPETENCE (heart valve did not close properly), SKIN MASS (nodules underneath skin tissue), SUTURE RELATED COMPLICATION (bad reaction to suture), POST PROCEDURAL COMPLICATION (bad reaction to rotator cuff surgery), DYSPHAGIA (could not swallow), HERPES ZOSTER (Shingles), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, ROTATOR CUFF SYNDROME (possible rotator cuff issue), MELANOCYTIC NAEVUS (possible mole issue), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), NERVOUS SYSTEM DISORDER (central nervous system was blown), CARDIAC DISORDER (flare up in heart), HEART VALVE INCOMPETENCE (heart valve did not close properly), SKIN MASS (nodules underneath skin tissue), SUTURE RELATED COMPLICATION (bad reaction to suture), POST PROCEDURAL COMPLICATION (bad reaction to rotator cuff surgery), DYSPHAGIA (could not swallow), HERPES ZOSTER (Shingles), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown and CROHN'S DISEASE (crohn's disease flare up) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Bone densitometry: messed up bone density. On an unknown date, Laboratory test: It did not look good.   The patient was messed up with the bone density and her central nervous system blown with prednisone. She also noted having flare up after being treated with Hydroxychloroquine. She had flare up in the heart as well and valve did not close properly and might need surgery. She also experienced having nodules underneath skin tissueafter having mole surgery for unknown reason. Physician was running tests such as unknown stool exam with unknown dates and unknown results and was considering upping the Humira dose.  On an unknown date patient had stool exam however result was unknown.  It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.  The reporter's causality for the event(s) of possible rotator cuff issue, possible mole issue, central nervous system was blown, flare up in heart, heart valve did not close properly, nodules underneath skin tissue, bad reaction to suture, bad reaction to rotator cuff surgery, could not swallow, rheumatoid arthritis flare up and shingles was not provided. The reporter's causality for the event(s) of crohn's disease flare up with HUMIRA(ADALIMUMAB) was a reasonable possibility. Agency's opinion is that there is no reasonable possibility that the events of possible rotator cuff issue, heart valve did not close properly, bad reaction to suture, bad reaction to rotator cuff surgery, rheumatoid arthritis flare up and crohn's disease flare up are related to HUMIRA(ADALIMUMAB). Agency's opinion is that the events of possible mole issue, central nervous system was blown, flare up in heart, nodules underneath skin tissue, could not swallow and shingles are not assessable.  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 is a spontaneous case concerning an elderly female patient with medical history of Crohn's disease and Rheumatoid arthritis, who experienced the unexpected, serious (medically significant) events of Rotator cuff syndrome, Melanocytic naevus, Crohn's disease (crohn's disease flare up) and the unexpected, serious (medically significant) adverse event of special interest of Rheumatoid arthritis (rheumatoid arthritis flare up), after receiving the second dose of mRNA-1273 vaccine. The patient underwent surgery for the mole of the skin. Exact date of vaccination, onset date of the events, clinical course, diagnostic tests and further treatment details were not provided in the case. At the time of the report, the event Crohn's disease (crohn's disease flare up) had resolved while the outcome of the rest of the events were unknown. Medical history of Crohn's disease and Rheumatoid arthritis remain as risk factor for its respective event of Crohn's disease and Rheumatoid arthritis. Revaccination with different COVID-19 vaccine and Interchange of vaccine products were also reported as additional events. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Mar-2022: Live follow-up received additional event information, reporter opinion of causality of co-suspects and co-suspect description and narrative was updated.; Sender's Comments: This is a spontaneous case concerning an elderly female patient with medical history of Crohn's disease and Rheumatoid arthritis, who experienced the unexpected, serious (medically significant) events of Rotator cuff syndrome, Melanocytic naevus, Crohn's disease (crohn's disease flare up) and the unexpected, serious (medically significant) adverse event of special interest of Rheumatoid arthritis (rheumatoid arthritis flare up), after receiving the second dose of mRNA-1273 vaccine. The patient underwent surgery for the mole of the skin. Exact date of vaccination, onset date of the events, clinical course, diagnostic tests and further treatment details were not provided in the case. At the time of the report, the event Crohn's disease (crohn's disease flare up) had resolved while the outcome of the rest of the events were unknown. Medical history of Crohn's disease and Rheumatoid arthritis remain as risk factor for its respective event of Crohn's disease and Rheumatoid arthritis. Revaccination with different COVID-19 vaccine and Interchange of vaccine products were also reported as additional events. The benefit-risk relationship of mRNA-1273 is not affected by this report.