Received Sep 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 3 | — | IM |
autoimmune disease, rheumatoid arthritis/ joint pain/swelling in her legs and feet and could hardly lift her arms; autoimmune disease; her head felt like concrete (second dose); felt dizzy (second dose); bad stomach pains; old surgical scars (from surgical removal of her ovaries and fallopian tubes 5 years earlier) hurt more than after her original surgery.; shortness of breath; panic attack; Could not sleep; chest pains; After the first dose (date unknown) the reporter states that she experienced high fevers of 104' for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (autoimmune disease, rheumatoid arthritis/ joint pain/swelling in her legs and feet and could hardly lift her arms) and AUTOIMMUNE DISORDER (autoimmune disease) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Salpingo-oophorectomy NOS (surgical removal of her ovaries and fallopian tubes 5 years earlier.) in 2020. Concurrent medical conditions included BRCA1 gene mutation (tested positive for BRCA gene.). On 14-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced ABDOMINAL PAIN UPPER (bad stomach pains) and SCAR PAIN (old surgical scars (from surgical removal of her ovaries and fallopian tubes 5 years earlier) hurt more than after her original surgery.). In 2022, the patient experienced DYSPNOEA (shortness of breath), PANIC ATTACK (panic attack), INSOMNIA (Could not sleep) and CHEST PAIN (chest pains). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (autoimmune disease, rheumatoid arthritis/ joint pain/swelling in her legs and feet and could hardly lift her arms) (seriousness criterion medically significant), AUTOIMMUNE DISORDER (autoimmune disease) (seriousness criterion medically significant), HEAD DISCOMFORT (her head felt like concrete (second dose)), DIZZINESS (felt dizzy (second dose)) and PYREXIA (After the first dose (date unknown) the reporter states that she experienced high fevers of 104' for 2 days). At the time of the report, RHEUMATOID ARTHRITIS (autoimmune disease, rheumatoid arthritis/ joint pain/swelling in her legs and feet and could hardly lift her arms), ABDOMINAL PAIN UPPER (bad stomach pains), SCAR PAIN (old surgical scars (from surgical removal of her ovaries and fallopian tubes 5 years earlier) hurt more than after her original surgery.), DYSPNOEA (shortness of breath), PANIC ATTACK (panic attack) and INSOMNIA (Could not sleep) had not resolved, AUTOIMMUNE DISORDER (autoimmune disease), HEAD DISCOMFORT (her head felt like concrete (second dose)) and DIZZINESS (felt dizzy (second dose)) outcome was unknown and CHEST PAIN (chest pains) and PYREXIA (After the first dose (date unknown) the reporter states that she experienced high fevers of 104' for 2 days) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, BRCA1 gene mutation assay: Positive. On an unknown date, Body temperature: 104. No concomitant medications were reported. Patient had an autoimmune disease and rheumatoid arthritis, and it all started the day she had the Moderna vaccine. Patient had 3 doses of the Moderna vaccine. After the first dose (date unknown), she experienced high fever of 104degree for 2 days. After the second dose (date unknown), she missed a week of work due to pain all over her body, her head felt like concrete, and she felt dizzy. She did not want to get the third dose, but her workplace required it, so she did not lose her job. After the third dose, she experienced pain all over her body, bad stomach pains, and old surgical scars (from surgical removal of her ovaries and fallopian tubes 5 years earlier) hurt more than after her original surgery. She also experienced chest pains, shortness of breath and joint pain. She went to the emergency room (ER), since her HCP would not treat her. She missed work for a week and was unable to sleep. She also experienced chest pain for 2 months and swelling in her legs and feet and could hardly lift her arms. Patient was diagnosed with rheumatoid arthritis this time last year. Prior to the vaccine, she was 100percent healthy, running 5 miles, 3 times a week but now she still had SOB when talking. It was unknown if the patient experienced any additional symptoms/events. She was treated in the ER as if she was having a panic attack and sent home. Reporter causality was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-788977, US-MODERNATX, INC.-MOD-2025-788978, US-MODERNATX, INC.-MOD-2025-788980 (E2B Linked Report).; Reporter's Comments: Past surgical history is a contributor for scar pain. The benefit -risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788977:Patient 1 of 3 US-MODERNATX, INC.-MOD-2025-788980:Patient 3 of 3 US-MODERNATX, INC.-MOD-2025-788978:Patient 2 of 3
BRCA1 gene mutation (tested positive for BRCA gene.)
Medical History/Concurrent Conditions: Salpingo-oophorectomy NOS (surgical removal of her ovaries and fallopian tubes 5 years earlier.)
Test Name: Body temperature; Result Unstructured Data: 104; Test Name: BRCA1 gene mutation; Test Result: Positive