Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Limb operation
Clinical narrative: Vaccination adverse reaction; Hand operation; This spontaneous case was reported by a consumer and describes the occurrence of LIMB OPERATION (Hand operation) in a 57-year-old male 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) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In July 2021, the patient experienced LIMB OPERATION (Hand operation) (seriousness criterion medically significant). On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). In 2021, LIMB OPERATION (Hand operation) had resolved. At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.  The reporter's causality for the event(s) of hand surgery and side effects from Covid vaccine with Humira(adalimumab) was no reasonable possibility.  No treatment medication was 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 is a Spontaneous case reported by a consumer, concerning a 57-year-old male patient, with relevant medical condition of rheumatoid arthritis, who experienced the unexpected and serious (due to medically significant) event of Limb operation (reported as hand operation), which occurred related to an unspecified dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect product included non-company product Adalimumab for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. The event resolved within 6 months. Underlying rheumatoid arthritis could be a confounding factor for Limb operation. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 57-year-old male patient, with relevant medical condition of rheumatoid arthritis, who experienced the unexpected and serious (due to medically significant) event of Limb operation (reported as hand operation), which occurred related to an unspecified dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect product included non-company product Adalimumab for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. The event resolved within 6 months. Underlying rheumatoid arthritis could be a confounding factor for Limb operation. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.