Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Blood test, Gastritis, Hypotension
Clinical narrative: RA to come out of remission; I itched all over; My BP bottomed out; I am still very weak; Severe acute gastroatitis; vertigo; This spontaneous case was reported by a patient and describes the occurrence of RHEUMATOID ARTHRITIS (RA to come out of remission) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 0121421B and 0101A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis since 02-Mar-2006, Fibromyalgia since 02-Mar-2006, Osteoarthritis since 02-Mar-2006, Immunocompromised and Viral pneumonia (5 years ago).   On 05-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Dec-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (RA to come out of remission) (seriousness criterion medically significant), PRURITUS (I itched all over), HYPOTENSION (My BP bottomed out), ASTHENIA (I am still very weak), GASTRITIS (Severe acute gastroatitis) and VERTIGO (vertigo). At the time of the report, RHEUMATOID ARTHRITIS (RA to come out of remission), PRURITUS (I itched all over), HYPOTENSION (My BP bottomed out), ASTHENIA (I am still very weak), GASTRITIS (Severe acute gastroatitis) and VERTIGO (vertigo) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2022, Blood test: Cholesterol a little high, all other was great. On an unknown date, Blood pressure measurement: BP level bottomed out. On an unknown date, Oxygen saturation: O2 level bottomed out.         No concomitant medications were reported. She would receive the biovalent hopefully in September. The coronavirus was very ugly devil. It had caused her rheumatoid arthritis to come out of remission. The coronavirus had also caused the patient vertigo. She had severe acute gastroatitis. The patients doctor told her that if she had not had the vaccines, she would probably not be alive. Her supplement did not go into effect until 06-Aug-2022. Her doctor told that to see her to every other day for checkup. She was a survivor of deadly virus. Treatment information was not provided. Company comment: This spontaneous case concerns a 69-years-old female patient, with   medical history of Rheumatoid arthritis, Fibromyalgia and Osteoarthritis since 02-Mar-2006, Immunocompromised and Viral pneumonia 5 years ago and Co-suspect product PAXLOVID who experienced the unexpected events of rheumatoid arthritis (AESI and seriousness criterion medically significant), the unexpected events of pruritus, hypotension, asthenia, gastritis and vertigo beginning unknown days after 4th. dose of mRNA-1273 vaccine. Also, inappropriate schedule of product administration was noted in this case. On an unknown date, the patient received PAXLOVID. The medical history of Rheumatoid arthritis, Fibromyalgia and Osteoarthritis are confounders for the event Rheumatoid arthritis. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.   This case was linked to MOD-2022-628400 (Patient Link).; Sender's Comments: This spontaneous case concerns a 69-years-old female patient, with   medical history of Rheumatoid arthritis, Fibromyalgia and Osteoarthritis since 02-Mar-2006, Immunocompromised and Viral pneumonia 5 years ago and Co-suspect product PAXLOVID who experienced the unexpected events of rheumatoid arthritis (AESI and seriousness criterion medically significant), the unexpected events of pruritus, hypotension, asthenia, gastritis and vertigo beginning unknown days after 4th. dose of mRNA-1273 vaccine. Also, inappropriate schedule of product administration was noted in this case. On an unknown date, the patient received PAXLOVID. The medical history of Rheumatoid arthritis, Fibromyalgia and Osteoarthritis are confounders for the event Rheumatoid arthritis. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.