Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Hand deformity, Pruritus, Stenosis
Clinical narrative: Hand deformity/arthritis pain/affecting the look of hands unknown onset; Arthritic pains/affecting the look of hands unknown onset; COVID-19; Itching; Stenosis/strictures; vaccination failure; This spontaneous case was reported by a consumer and describes the occurrence of STENOSIS (Stenosis/strictures), PRURITUS (Itching), HAND DEFORMITY (Hand deformity/arthritis pain/affecting the look of hands unknown onset), COVID-19 (COVID-19) and ARTHRALGIA (Arthritic pains/affecting the look of hands unknown onset) in a 68-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 product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and Rheumatoid arthritis.    The patient's past medical history included Ulcer and Hospitalization (She was hospitalized in the past.). Concurrent medical conditions included Osteoporosis, Rheumatoid arthritis and Crohn's disease.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second 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) UNK, Citrate Free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK, Citrate Free. In 2021, the patient experienced STENOSIS (Stenosis/strictures) (seriousness criterion hospitalization). On 21-Dec-2021, the patient experienced PRURITUS (Itching) (seriousness criterion hospitalization) and COVID-19 (COVID-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced HAND DEFORMITY (Hand deformity/arthritis pain/affecting the look of hands unknown onset) (seriousness criterion hospitalization), ARTHRALGIA (Arthritic pains/affecting the look of hands unknown onset) (seriousness criterion hospitalization) and VACCINATION FAILURE (vaccination failure). At the time of the report, STENOSIS (Stenosis/strictures), PRURITUS (Itching), HAND DEFORMITY (Hand deformity/arthritis pain/affecting the look of hands unknown onset), COVID-19 (COVID-19), ARTHRALGIA (Arthritic pains/affecting the look of hands unknown onset) and VACCINATION FAILURE (vaccination failure) outcome was unknown.            No concomitant medication details were provided. No treatment medication details were provided.   The patient had arthritis pain. It was affecting the look of her hands. Weather affected it.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality as per reporter for hospitalization was reported as possible with Moderna COVID-19 Vaccine.  The reporter's causality for the events with HUMIRA was not provided.  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 68 years with relevant medical history of RHEUMATOID ARTHRITIS reported, who experienced the unexpected serious (hospitalization) events of Stenosis, Pruritus, Hand deformity, COVID-19 (AESI) and Arthralgia in the context of mRNA-1273 vaccination. Patient had received 1st and 2nd doses of same vaccine at an interval of 28 days. COVID-19 and Pruritus occurred approximately 7 months after 2nd dose. Hence Vaccination failure was also noted.  Rest of the events occurred on unknown dates. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the events was not known at the time of report. Relevant medical history remains a confounder to the events Hand deformity and Arthralgia. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement; Sender's Comments: This spontaneous case concerns a female patient aged 68 years with relevant medical history of RHEUMATOID ARTHRITIS reported, who experienced the unexpected serious (hospitalization) events of Stenosis, Pruritus, Hand deformity, COVID-19 (AESI) and Arthralgia in the context of mRNA-1273 vaccination. Patient had received 1st and 2nd doses of same vaccine at an interval of 28 days. COVID-19 and Pruritus occurred approximately 7 months after 2nd dose. Hence Vaccination failure was also noted.  Rest of the events occurred on unknown dates. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the events was not known at the time of report. Relevant medical history remains a confounder to the events Hand deformity and Arthralgia. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement