Age: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Adverse drug reaction, Device malfunction, Drug dose omission by device, Drug hypersensitivity, Rash
Clinical narrative: EMBREL DID NOT WORK/ PUNCTURED SKIN BUT PEN MALFUNCTIONED/FELT THE NEEDLE BUT MEDICATION REMAINED INSIDE THE PEN/YELLOW INDICATOR WAS NOT OBSERVED.; EMBREL DID NOT WORK/ PUNCTURED SKIN BUT PEN MALFUNCTIONED/FELT THE NEEDLE BUT MEDICATION REMAINED INSIDE THE PEN/YELLOW INDICATOR WAS NOT OBSERVED.; Rash; SULFA DRUG ALLERGY; Rheumatoid arthritis; POSSIBLE REACTION TO CELEBREX; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) in a 52-year-old female patient who received mRNA-1273 (Spikevax) 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, CELECOXIB (CELEBREX) for an unknown indication, ETANERCEPT (ENBREL) for an unknown indication and SULFAMETHOXAZOLE, TRIMETHOPRIM (SULFONAMIDE) for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis.   On 01-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Apr-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 03-May-2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On an unknown date, the patient started CELECOXIB (CELEBREX) (unknown route) at an unspecified dose, ETANERCEPT (ENBREL) (unknown route) at an unspecified dose and SULFAMETHOXAZOLE, TRIMETHOPRIM (SULFONAMIDE) (unknown route) at an unspecified dose. On 03-May-2022, the patient experienced DRUG DOSE OMISSION BY DEVICE (EMBREL DID NOT WORK/ PUNCTURED SKIN BUT PEN MALFUNCTIONED/FELT THE NEEDLE BUT MEDICATION REMAINED INSIDE THE PEN/YELLOW INDICATOR WAS NOT OBSERVED.) and DEVICE MALFUNCTION (EMBREL DID NOT WORK/ PUNCTURED SKIN BUT PEN MALFUNCTIONED/FELT THE NEEDLE BUT MEDICATION REMAINED INSIDE THE PEN/YELLOW INDICATOR WAS NOT OBSERVED.). In 2022, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant), ADVERSE DRUG REACTION (POSSIBLE REACTION TO CELEBREX), RASH (Rash) and DRUG HYPERSENSITIVITY (SULFA DRUG ALLERGY). On 03-May-2022, DEVICE MALFUNCTION (EMBREL DID NOT WORK/ PUNCTURED SKIN BUT PEN MALFUNCTIONED/FELT THE NEEDLE BUT MEDICATION REMAINED INSIDE THE PEN/YELLOW INDICATOR WAS NOT OBSERVED.) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis), ADVERSE DRUG REACTION (POSSIBLE REACTION TO CELEBREX), DRUG DOSE OMISSION BY DEVICE (EMBREL DID NOT WORK/ PUNCTURED SKIN BUT PEN MALFUNCTIONED/FELT THE NEEDLE BUT MEDICATION REMAINED INSIDE THE PEN/YELLOW INDICATOR WAS NOT OBSERVED.), RASH (Rash) and DRUG HYPERSENSITIVITY (SULFA DRUG ALLERGY) outcome was unknown.            No concomitant and treatment medications were reported.  Reporters causality for event device issue was probable and for all other events was not reported with respect to Humira drug. Reporters causality for event adverse drug reaction was probable and for all other events was not reported with respect to Celebrex drug. Reporters causality for event Lack of drug effect was probable and for all other events was not reported with respect to Enbrel drug. Reporters causality for event Sulfonamide allergy was probable and for all other events was not reported with respect to sulfonamide drug.  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 female patient aged 52 years with reported concurrent condition of rheumatoid arthritis on Humira, experienced unexpected serious (medically significant) AESI of Rheumatoid arthritis on unknown dates (in 2022) after second dose of mRNA-1273 vaccination. No further information on detailed clinical course, investigations was available in the report.  Outcome of the events was unknown at the time of report. Patient had received initial two doses of same vaccine at an interval of 1 month. Relevant concurrent condition of rheumatoid arthritis remains a confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient aged 52 years with reported concurrent condition of rheumatoid arthritis on Humira, experienced unexpected serious (medically significant) AESI of Rheumatoid arthritis on unknown dates (in 2022) after second dose of mRNA-1273 vaccination. No further information on detailed clinical course, investigations was available in the report.  Outcome of the events was unknown at the time of report. Patient had received initial two doses of same vaccine at an interval of 1 month. Relevant concurrent condition of rheumatoid arthritis remains a confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.