Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Chills, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: Minor flare up of rheumatoid arthritis; Patient received 1st and 2nd doses of Tozinameran vaccine/n 02 Dec 2021, patient received Booster dose COVID-19 Vaccine manufactured by Moderna; Patient received 1st and 2nd doses of Tozinameran vaccine/n 02 Dec 2021, patient received Booster dose COVID-19 Vaccine manufactured by Moderna; the 2nd dose given 9 months prior to the mRNA-1273 vaccine; Booster dose caused sore arm; Booster dose caused fatigue; Booster dose caused chills; Booster dose caused headache; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Minor flare up of rheumatoid arthritis) in a 47-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 product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (Route: Intramuscular, Adverse reaction included vaccine caused fatigue and vaccination caused headache (start date: Mar-2021; stop date: Mar-2021)) on 03-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Route: Intramuscular and Adverse reaction included vaccine caused sore arm and vaccination caused headache (start date: Mar-2021; stop date: Mar-2021)) on 24-Mar-2021. Past adverse reactions to the above products included Fatigue with PFIZER BIONTECH COVID-19 VACCINE; and Vaccination site pain with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Rheumatoid arthritis.   On 02-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) at an unspecified dose once a week. In December 2021, the patient experienced VACCINATION SITE PAIN (Booster dose caused sore arm), FATIGUE (Booster dose caused fatigue), CHILLS (Booster dose caused chills) and HEADACHE (Booster dose caused headache). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Minor flare up of rheumatoid arthritis) (seriousness criterion medically significant), COVID-19 IMMUNISATION (Patient received 1st and 2nd doses of Tozinameran vaccine/n 02 Dec 2021, patient received Booster dose COVID-19 Vaccine manufactured by Moderna), INTERCHANGE OF VACCINE PRODUCTS (Patient received 1st and 2nd doses of Tozinameran vaccine/n 02 Dec 2021, patient received Booster dose COVID-19 Vaccine manufactured by Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the 2nd dose given 9 months prior to the mRNA-1273 vaccine). In December 2021, VACCINATION SITE PAIN (Booster dose caused sore arm), FATIGUE (Booster dose caused fatigue), CHILLS (Booster dose caused chills) and HEADACHE (Booster dose caused headache) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Minor flare up of rheumatoid arthritis) had not resolved and COVID-19 IMMUNISATION (Patient received 1st and 2nd doses of Tozinameran vaccine/n 02 Dec 2021, patient received Booster dose COVID-19 Vaccine manufactured by Moderna), INTERCHANGE OF VACCINE PRODUCTS (Patient received 1st and 2nd doses of Tozinameran vaccine/n 02 Dec 2021, patient received Booster dose COVID-19 Vaccine manufactured by Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the 2nd dose given 9 months prior to the mRNA-1273 vaccine) outcome was unknown.            No concomitant medication was reported.  The co-suspect Humira formulation was reported as solution for injection in pre-filled pen. On 02-Dec-2021, the patient received the booster dose of Moderna COVID-19 vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was reported.  The reporter causality for the events vaccine caused sore arm, booster dose caused sore arm, vaccine caused fatigue, booster dose caused fatigue, booster dose caused chills, minor flare up of rheumatoid arthritis, vaccine caused headache and booster dose caused headache with co-suspect Humira was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  company comment: This spontaneous case concerns a 47-year-old female patient, with concurrent medical history of rheumatoid arthritis treated with co-suspect drug Adalimumab (start date unknown), who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as minor flare up of rheumatoid arthritis) on an unknown date after receiving the mRNA-1273 vaccine as a booster dose. Clinical course and treatment details were not reported. The outcome of event was reported as not resolved. Patient received 1st and 2nd doses of Tozinameran vaccine (Interchange of vaccine products noted), with the 2nd dose given 9 months prior to the mRNA-1273 vaccine (Inappropriate schedule of product administration). Concurrent rheumatoid arthritis and co-suspect Adalimumab could be confounders as the disease flares up. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 47-year-old female patient, with concurrent medical history of rheumatoid arthritis treated with co-suspect drug Adalimumab (start date unknown), who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as minor flare up of rheumatoid arthritis) on an unknown date after receiving the mRNA-1273 vaccine as a booster dose. Clinical course and treatment details were not reported. The outcome of event was reported as not resolved. Patient received 1st and 2nd doses of Tozinameran vaccine (Interchange of vaccine products noted), with the 2nd dose given 9 months prior to the mRNA-1273 vaccine (Inappropriate schedule of product administration). Concurrent rheumatoid arthritis and co-suspect Adalimumab could be confounders as the disease flares up. The benefit-risk relationship of mRNA-1273 is not affected by this report.