Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Immunisation reaction, Inflammation, Myalgia
Clinical narrative: Fatigue; Inflammation; Joint pain; Muscle soreness; Swelling of legs; Vaccination adverse reaction; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in right leg) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Achilles tendonitis, Bone spur, Rheumatoid arthritis and Meniscus tear (right).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced PERIPHERAL SWELLING (swelling in right leg) (seriousness criterion medically significant), INFLAMMATION (inflammation shown on labs), ARTHRALGIA (Joint pain), MYALGIA (Muscle soreness) and FATIGUE (Fatigue). On an unknown date, the patient experienced IMMUNISATION REACTION (vaccine related issues/sore arm after all three covid vaccine) and VACCINATION SITE PAIN (vaccine related issues/sore arm after all three covid vaccine). At the time of the report, PERIPHERAL SWELLING (swelling in right leg), INFLAMMATION (inflammation shown on labs), IMMUNISATION REACTION (vaccine related issues/sore arm after all three covid vaccine), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (vaccine related issues/sore arm after all three covid vaccine) and FATIGUE (Fatigue) outcome was unknown and MYALGIA (Muscle soreness) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Inflammation: unknown.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       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.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No concomitant medication was provided by reporter. No treatment medication was provided by reporter.  Company Comment:  This is a spontaneous case, reported by a consumer, concerning a 75-year-old female patient with relevant medical condition of moderate to severe Rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Peripheral swelling, reported as swelling of right leg, which occurred approximately 5 months after receiving a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since the exact event onset date was not provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 28 days which falls within the recommended vaccine dosing schedule, prior to third/booster mRNA-1273 vaccination. The patient also experienced very minor fatigue, muscle soreness, right meniscus tear, swelling in right leg and had vein surgery, joint pain, inflammation shown on labs, vaccine related issues, and sore arm after all three COVID-19 vaccines. No further details about the other diagnostic procedures and treatments were provided. Outcome of the event Peripheral swelling was unknown. The medical condition of moderate to severe Rheumatoid arthritis remains as a confounder for the event Peripheral swelling. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-626001 (Patient Link).; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 75-year-old female patient with relevant medical condition of moderate to severe Rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Peripheral swelling, reported as swelling of right leg, which occurred approximately 5 months after receiving a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since the exact event onset date was not provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 28 days which falls within the recommended vaccine dosing schedule, prior to third/booster mRNA-1273 vaccination. The patient also experienced very minor fatigue, muscle soreness, right meniscus tear, swelling in right leg and had vein surgery, joint pain, inflammation shown on labs, vaccine related issues, and sore arm after all three COVID-19 vaccines. No further details about the other diagnostic procedures and treatments were provided. Outcome of the event Peripheral swelling was unknown. The medical condition of moderate to severe Rheumatoid arthritis remains as a confounder for the event Peripheral swelling. The benefit-risk relationship of mRNA-1273 is not affected by this report.