Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram, Rheumatoid arthritis, Ultrasound scan
Clinical narrative: Rheumatoid arthritis; armpit area was red/ pin woke her up in the night/ painful lymph nodes/ very, very painful for her to even try to reach her arms up /had swelling of the lymph nodes; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient never had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Seasonal allergy.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced LYMPHADENOPATHY (armpit area was red/ pin woke her up in the night/ painful lymph nodes/ very, very painful for her to even try to reach her arms up /had swelling of the lymph nodes). On 10-Apr-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant). The patient was treated with IBUPROFEN for Armpit pain, at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis) and LYMPHADENOPATHY (armpit area was red/ pin woke her up in the night/ painful lymph nodes/ very, very painful for her to even try to reach her arms up /had swelling of the lymph nodes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Mammogram: came back normal. In 2021, Ultrasound scan: showed the lymph nodes were a little swollen.         Concomitant medication was not reported.  Patient started experiencing symptoms approximately 2 weeks after receiving the 2nd dose. He says that the lump was very apparent. The pain made her cry due to painful armpit. Armpit area was swollen, red, and painful to touch. She was told by her doctor to do warm compresses and take Ibuprofen. She was told by her doctor to be careful with the arm. She can't pick up anything heavy due to the pain. When she tries to pick up heavy things, she feels like it could lead to some type of issue. She cannot put groceries in her van and she needs someone with her to be able to do that. She had received 2 more doses of the Moderna COVID-19 vaccine after this; however, her symptoms have remained stable. The patient did not experience a similar event in the past.  Company comment- This spontaneous case concerns a 60-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) AESI Rheumatoid arthritis along with the non-serious expected event of lymphadenopathy approximately 2 weeks after a second dose of mRNA-1273 vaccine was administered.  It was reported patient had a very apparent lump. The pain made her cry due to painful armpit. Armpit area was swollen, red, and painful to touch. She was told by her doctor to do warm compresses and take Ibuprofen. She can't pick up anything heavy due to the pain. She had received 2 more doses of the mRNA-1273 vaccine after this; however, her symptoms have remained stable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-667375 (E2B Linked Report).; Sender's Comments: This spontaneous case concerns a 60-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) AESI Rheumatoid arthritis along with the non-serious expected event of lymphadenopathy approximately 2 weeks after a second dose of mRNA-1273 vaccine was administered.  It was reported patient had a very apparent lump. The pain made her cry due to painful armpit. Armpit area was swollen, red, and painful to touch. She was told by her doctor to do warm compresses and take Ibuprofen. She can't pick up anything heavy due to the pain. She had received 2 more doses of the mRNA-1273 vaccine after this; however, her symptoms have remained stable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-667375:Crosslink ID (MOD22-028291)