Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Malaise, Rheumatoid arthritis, Swelling, Vertigo
Clinical narrative: Rheumatoid arthritis flare up; Vertigo; Swelling; Did not feel well; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), VERTIGO (Vertigo), SWELLING (Swelling), MALAISE (Did not feel well) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and Plaque psoriasis.    Previously administered products included for COVID-19 vaccination: Pfizer Biontech COVID-19 vaccine (first dose (1 in 1 once), Intramuscular) on 31-Dec-2020, Pfizer Biontech COVID-19 vaccine (second dose (1 in 1 once) and Intramuscular) on 25-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer Biontech COVID-19 vaccine and Pfizer Biontech COVID-19 vaccine. Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS) and Plaque psoriasis (MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS).   On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On 30-Dec-2021, the patient experienced VERTIGO (Vertigo), SWELLING (Swelling), MALAISE (Did not feel well) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up). In January 2022, VERTIGO (Vertigo), SWELLING (Swelling) and MALAISE (Did not feel well) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality with Humira for the events of rheumatoid arthritis flare up, vertigo, swelling and did not feel well was no reasonable possibility.  No treatment information was provided. Company comment: This spontaneous case concerns a 46-year-old female patient, with medical history of rheumatoid arthritis, who experienced the non-serious unexpected AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), among other non-serious adverse events. The event was reported with no onset date; hence, latency cannot be assessed to the dose of mRNA-1273 vaccine, considered as the third dose of the vaccine schedule. Previously she received two doses of Pfizer Biontech COVID-19 vaccine as primary schedule. The medical history remains as a confounder for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 46-year-old female patient, with medical history of rheumatoid arthritis, who experienced the non-serious unexpected AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), among other non-serious adverse events. The event was reported with no onset date; hence, latency cannot be assessed to the dose of mRNA-1273 vaccine, considered as the third dose of the vaccine schedule. Previously she received two doses of Pfizer Biontech COVID-19 vaccine as primary schedule. The medical history remains as a confounder for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.