Age: 68.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Dermatitis contact, Immunisation reaction, Surgery, Swelling
Clinical narrative: Vaccination adverse reaction; Swelling; Cosmetic allergy; surgery; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (surgery) in a 68-year-old patient of an unknown gender 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) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free 40mg/0.4ml,1 in 2 wk. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction), SWELLING (Swelling), DERMATITIS CONTACT (Cosmetic allergy) and SURGERY (surgery) (seriousness criterion medically significant). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction), SWELLING (Swelling), DERMATITIS CONTACT (Cosmetic allergy) and SURGERY (surgery) outcome was unknown.            No concomitant medications were reported. Patient has undergo to surgery on an unknown date. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No treatment medications were reported.  Company comment: This is a spontaneous case concerning a elderly patient of unknown gender with relevant concurrent medical condition of psoriatic arthritis. Patient has co-suspect medication of Adalimumab (Humira) with subcutaneous route of administration for psoriatic arthritis. Patient experienced the unexpected non-serious events of immunisation reaction, dermatitis contact (cosmetic allergy), and swelling. Surgery was also reported as medically significant. On 9 March 2021 patient received first dose of mRNA-1273 vaccine. On 6 April 2021, patient received second dose of mRNA-1273 vaccine. On unknown date patient received co-suspect medication of Adalimumab (Humira). On unknown date patient underwent unspecified surgery, and experienced immunisation reaction, dermatitis contact (cosmetic allergy), and unspecified swelling. The concurrent medical condition of psoriatic arthritis and the subcutaneous route of administration for the co-suspect medication of Adalimumab (Humira) may remain confounders for the event swelling. No other information surrounding the events was reported. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a elderly patient of unknown gender with relevant concurrent medical condition of psoriatic arthritis. Patient has co-suspect medication of Adalimumab (Humira) with subcutaneous route of administration for psoriatic arthritis. Patient experienced the unexpected non-serious events of immunisation reaction, dermatitis contact (cosmetic allergy), and swelling. Surgery was also reported as medically significant. On 9 March 2021 patient received first dose of mRNA-1273 vaccine. On 6 April 2021, patient received second dose of mRNA-1273 vaccine. On unknown date patient received co-suspect medication of Adalimumab (Humira). On unknown date patient underwent unspecified surgery, and experienced immunisation reaction, dermatitis contact (cosmetic allergy), and unspecified swelling. The concurrent medical condition of psoriatic arthritis and the subcutaneous route of administration for the co-suspect medication of Adalimumab (Humira) may remain confounders for the event swelling. No other information surrounding the events was reported. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.