Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Feeling abnormal, Inappropriate schedule of product administration, Liver disorder, Menopause
Clinical narrative: Dose 1 on 11Mar2021 and dose 2 on 04Apr2021; RA was worse/ Excessive swelling, excessive exhaustion/ Experienced more swelling and stiffness; Liver disease; Psoriasis all over legs and arms/Rash would not go away/ Sores all over her/ Sores/ Lower leg is covered in sores, arms, back has three/ There are a couple on her eye; Miserable/ Is so upset/ Suffering while her bones get eaten/ Been through a ringer, hell and back because of this vaccine; She states that the vaccine also threw me into menopause; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RA was worse/ Excessive swelling, excessive exhaustion/ Experienced more swelling and stiffness) and PSORIASIS (Psoriasis all over legs and arms/Rash would not go away/ Sores all over her/ Sores/ Lower leg is covered in sores, arms, back has three/ There are a couple on her eye) in a 50-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.     Patient never had COVID positive test or diagnosis.  The patient's past medical history included Immunocompromised. Previously administered products included for Rheumatoid arthritis: METHOTREXATE; for Product used for unknown indication: FLU SYRINGE. Past adverse reactions to the above products included No adverse event with FLU SYRINGE and METHOTREXATE. Concurrent medical conditions included Rheumatoid arthritis and Drug allergy (hydroxychloroquine). Concomitant products included ABATACEPT (ORENCIA) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 11Mar2021 and dose 2 on 04Apr2021). In 2021, the patient experienced RHEUMATOID ARTHRITIS (RA was worse/ Excessive swelling, excessive exhaustion/ Experienced more swelling and stiffness) (seriousness criterion medically significant), LIVER DISORDER (Liver disease), PSORIASIS (Psoriasis all over legs and arms/Rash would not go away/ Sores all over her/ Sores/ Lower leg is covered in sores, arms, back has three/ There are a couple on her eye) (seriousness criterion medically significant), FEELING ABNORMAL (Miserable/ Is so upset/ Suffering while her bones get eaten/ Been through a ringer, hell and back because of this vaccine) and MENOPAUSE (She states that the vaccine also threw me into menopause). The patient was treated with PREDNISONE at a dose of 1 dosage form. At the time of the report, RHEUMATOID ARTHRITIS (RA was worse/ Excessive swelling, excessive exhaustion/ Experienced more swelling and stiffness), LIVER DISORDER (Liver disease), PSORIASIS (Psoriasis all over legs and arms/Rash would not go away/ Sores all over her/ Sores/ Lower leg is covered in sores, arms, back has three/ There are a couple on her eye), FEELING ABNORMAL (Miserable/ Is so upset/ Suffering while her bones get eaten/ Been through a ringer, hell and back because of this vaccine) and MENOPAUSE (She states that the vaccine also threw me into menopause) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 11Mar2021 and dose 2 on 04Apr2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: no result reported (Inconclusive) Multiple biopsies, result was not reported. On an unknown date, Weight: high (High) Gained a load of weight.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RHEUMATOID ARTHRITIS (RA was worse/ Excessive swelling, excessive exhaustion/ Experienced more swelling and stiffness), LIVER DISORDER (Liver disease), PSORIASIS (Psoriasis all over legs and arms/Rash would not go away/ Sores all over her/ Sores/ Lower leg is covered in sores, arms, back has three/ There are a couple on her eye), FEELING ABNORMAL (Miserable/ Is so upset/ Suffering while her bones get eaten/ Been through a ringer, hell and back because of this vaccine) and MENOPAUSE (She states that the vaccine also threw me into menopause) to be related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 11Mar2021 and dose 2 on 04Apr2021).    After the 2nd dose, patient reported liver disease and psoriasis all over her legs and arms. Liver disease prevented the patient from taking RA meds which may have led to RA worsening. Persistence of symptoms prompted multiple consult and biopsies. Prednisone treatment was started and may have resulted to patient's weight gain.   Company Comment: This spontaneous case concerns a 50-year-old, female patient, with the relevant medical conditions of immunocompromised status & rheumatoid arthritis (RA), with a concomitant medication of Orencia & methotrexate treatment history for her RA, who experienced the unexpected, medically significant serious events of an AESI Rheumatoid arthritis & Psoriasis as well as an unexpected, non-serious AESI Liver disorder post-vaccination with a 2nd dose of mRNA-1273 vaccine. The exact onset latency of these events cannot be determined with unknown event onset dates. A 1st dose of mRNA-1273 vaccine was given 24 days before her 2nd vaccination. Reportedly, patient got liver disease and psoriasis all over her legs and arms after receiving the 2nd dose. Event liver disease prevented the patient from taking RA medications that may have resulted to more swelling and stiffness as her rheumatoid arthritis worsened. Event psoriasis may have further presented as sores covering her legs and a few sores on her arms, back, & eye. Persistence of symptoms prompted multiple consults and multiple biopsies. Prednisone treatment for 6 months was started. All the events have not resolved. Further details on the medical history, clinical course, diagnostic results, & treatment were not reported for medical review. Rheumatoid arthritis flares are expected in patients with a pre-existing RA regardless of vaccination status. Methotrexate can cause hepatotoxicity based on its product information. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement and the available information.   This case was linked to MOD-2022-576442, MOD-2022-576823 (Patient Link).; Sender's Comments: This spontaneous case concerns a 50-year-old, female patient, with the relevant medical conditions of immunocompromised status & rheumatoid arthritis (RA), with a concomitant medication of Orencia & methotrexate treatment history for her RA, who experienced the unexpected, medically significant serious events of an AESI Rheumatoid arthritis & Psoriasis as well as an unexpected, non-serious AESI Liver disorder post-vaccination with a 2nd dose of mRNA-1273 vaccine. The exact onset latency of these events cannot be determined with unknown event onset dates. A 1st dose of mRNA-1273 vaccine was given 24 days before her 2nd vaccination. Reportedly, patient got liver disease and psoriasis all over her legs and arms after receiving the 2nd dose. Event liver disease prevented the patient from taking RA medications that may have resulted to more swelling and stiffness as her rheumatoid arthritis worsened. Event psoriasis may have further presented as sores covering her legs and a few sores on her arms, back, & eye. Persistence of symptoms prompted multiple consults and multiple biopsies. Prednisone treatment for 6 months was started. All the events have not resolved. Further details on the medical history, clinical course, diagnostic results, & treatment were not reported for medical review. Rheumatoid arthritis flares are expected in patients with a pre-existing RA regardless of vaccination status. Methotrexate can cause hepatotoxicity based on its product information. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement and the available information.