Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SPINAL DEFORMITY (Curvature of spine), MUSCULOSKELETAL STIFFNESS (Limbs stiffness), RENAL DISORDER (Kidney disorder), STRESS (Stress) and PAIN IN EXTREMITY (Hand pain) in a 77-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) for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis (moderate to severe). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SPINAL DEFORMITY (Curvature of spine), MUSCULOSKELETAL STIFFNESS (Limbs stiffness), RENAL DISORDER (Kidney disorder), STRESS (Stress), PAIN IN EXTREMITY (Hand pain), AMNESIA (Memory loss), TASTE DISORDER (Taste disorder), PAIN IN EXTREMITY (Foot pain), COVID-19 (COVID-19), VACCINATION SITE PAIN (Vaccination site pain) and CHILLS (Chills). At the time of the report, SPINAL DEFORMITY (Curvature of spine), MUSCULOSKELETAL STIFFNESS (Limbs stiffness) and PAIN IN EXTREMITY (Hand pain) had not resolved, RENAL DISORDER (Kidney disorder), STRESS (Stress) and PAIN IN EXTREMITY (Foot pain) was resolving, AMNESIA (Memory loss), TASTE DISORDER (Taste disorder) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown and COVID-19 (COVID-19) and CHILLS (Chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: (Positive) Positive. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. No concomitant medications were reported. No treatment medications were reported. Patient took Humira (1150237 and 1132105). The reporter assessed the events of memory loss, taste disorder, kidney disorder, stress and COVID-19 to be not reasonably possible to Humira. The reporter assessed the events of foot pain, hand pain, limbs stiffness and curvature of spine as reasonably possible to Humira. The reporter did not provide any causality assessment for the events of vaccination site pain and chills with Humira. The reporter did not provide any causality assessment for the events of kidney disorder, stress, hand pain, limbs stiffness and curvature of spine with Moderna vaccine. The reporter assessed rest of the events as not related to Moderna vaccine. 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 77 - year - old female patient, in treatment with Adalimumab for Rheumatoid arthritis, who received a dose of mRNA - 1273 vaccine (described as first dose of her COVID - 19 immunization schedule), and experienced the unexpected, non - serious AESI of COVID - 19, among others adverse events. Vaccination date and exact onset date of COVID - 19 were not reported; hence latency and temporal association cannot be properly assessed. The outcome of COVID - 19 was recovered. No further details were provided for medical reviewing. Rheumatoid arthritis and co - suspect drug Adalimumab remain as risk factors for infections (COVID - 19). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up contains event details and updated narrative. On 17-Dec-2021: Follow up contains event details and updated narrative. Sender's Comments: This spontaneous case concerns a 77 - year - old female patient, in treatment with Adalimumab for Rheumatoid arthritis, who received a dose of mRNA - 1273 vaccine (described as first dose of her COVID - 19 immunization schedule), and experienced the unexpected, non - serious AESI of COVID - 19, among others adverse events. Vaccination date and exact onset date of COVID - 19 were not reported; hence latency and temporal association cannot be properly assessed. The outcome of COVID - 19 was recovered. No further details were provided for medical reviewing. Rheumatoid arthritis and co - suspect drug Adalimumab remain as risk factors for infections (COVID - 19). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.