Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, COVID-19, COVID-19 immunisation, Interchange of vaccine products, Middle insomnia
Clinical narrative: Waking up in the middle of the night; COVID-19; Revaccination with different COVID-19 vaccine; Interchange of vaccine products; Feel like body was on fire; RA flare was so bad; This spontaneous case was reported by a patient and describes the occurrence of RHEUMATOID ARTHRITIS (RA flare was so bad) in a 57-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 products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Previously administered products included for Drug use for unknown indication: BACTRIM. Past adverse reactions to the above products included No adverse event with BACTRIM. Concurrent medical conditions included Sulfonamide allergy, Allergy to antibiotic and Allergy to NSAIDs. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN), ACRIVASTINE (BENADRYL [ACRIVASTINE]), FLUTICASONE PROPIONATE, ALBUTEROL SULFATE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), PARACETAMOL (TYLENOL) and IBUPROFEN for an unknown indication.   In 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced RHEUMATOID ARTHRITIS (RA flare was so bad) (seriousness criterion medically significant) and BURNING SENSATION (Feel like body was on fire). On an unknown date, the patient experienced MIDDLE INSOMNIA (Waking up in the middle of the night), COVID-19 (COVID-19), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (RA flare was so bad) and BURNING SENSATION (Feel like body was on fire) had resolved and MIDDLE INSOMNIA (Waking up in the middle of the night), COVID-19 (COVID-19), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2022, SARS-CoV-2 test: (Positive) positive.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Company Comment: This spontaneous case concerns a 57-year-old female patient with relevant medical history of Rheumatoid Arthritis that was treated with Adalimumab (Humira), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up), unexpected non-serious AESI of COVID-19, and non-serious events of Middle insomnia and Burning sensation. The event COVID-19 occurred approximately 7 months after ,the event Middle insomnia occurred on an unknown date and the events Rheumatoid arthritis and Burning sensation occurred on an unknown date in 2021 while the third dose of mRNA-1273 was administered in Oct-2021. SARS-CoV-2 test was positive on 01-May-2022 (approximately 7 months after the third dose of mRNA-1273). COVID-19 immunisation and Interchange of vaccine products is also noted in this case as the patient received Pfizer BioNTech covid-19 vaccine on an unknown date. The medical history of Rheumatoid Arthritis remains a confounder to the events Rheumatoid arthritis flare up and Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 57-year-old female patient with relevant medical history of Rheumatoid Arthritis that was treated with Adalimumab (Humira), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up), unexpected non-serious AESI of COVID-19, and non-serious events of Middle insomnia and Burning sensation. The event COVID-19 occurred approximately 7 months after ,the event Middle insomnia occurred on an unknown date and the events Rheumatoid arthritis and Burning sensation occurred on an unknown date in 2021 while the third dose of mRNA-1273 was administered in Oct-2021. SARS-CoV-2 test was positive on 01-May-2022 (approximately 7 months after the third dose of mRNA-1273). COVID-19 immunisation and Interchange of vaccine products is also noted in this case as the patient received Pfizer BioNTech covid-19 vaccine on an unknown date. The medical history of Rheumatoid Arthritis remains a confounder to the events Rheumatoid arthritis flare up and Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.