Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Foot fracture, Psoriasis
Clinical narrative: Patient experienced broken bone in left foot; Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of FOOT FRACTURE (Patient experienced broken bone in left foot) and PSORIASIS (Psoriasis flare-up) in a 54-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) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS.).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK (Citrate free). On an unknown date, the patient experienced FOOT FRACTURE (Patient experienced broken bone in left foot) (seriousness criterion medically significant) and PSORIASIS (Psoriasis flare-up) (seriousness criterion medically significant). At the time of the report, FOOT FRACTURE (Patient experienced broken bone in left foot) and PSORIASIS (Psoriasis flare-up) outcome was unknown.            No concomitant was reported by patient.  Patient reported that on unknown date she experienced non serious psoriasis flare up upon receiving third Moderna dose, In 2022 patient experienced broken bone in left foot. Humira Solution for injection in pre filled pen was reported as co suspect product and patient stopped humira for foot surgery. Patient did not agreed to physician contacted. Humira stopped date was reported as 2022.  The reported causality for the event broken bone in left foot was not provided and for psoriasis flare up on receiving third dose of Moderna dose with Humira was not related. Abbevies opinion was that there was no possibility that both the events were related to Humira.  For Humira co suspect product action taken, causality as per reporter,  causality as per manufacturer and de challenge for event Broken foot was reported as Drug discontinued, not reported, no reasonable possibility and unknown respectively. Action taken, causality as per reporter, causality as per manufacturer and de challenge for event psoriasis flare up was reported as unknown, not related, no reasonable possibility and not applicable respectively.  No treatment medication was reported by patient.  Company comment: This spontaneous case concerns a 54-year-old female patient, on Adalimumab (Humira) due to Psoriasis, who experienced unexpected, serious (medically significant) events of Foot fracture and Psoriasis (reported as Psoriasis flare-up), unspecified days after receiving a dose of mRNA-1273 vaccine as a third dose. Temporal association cannot be assessed due to lack of information regarding the date of vaccination.  Clinical course, work-ups done, and treatment details are not available in this report.  The outcome of the events was unknown.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 54-year-old female patient, on Adalimumab (Humira) due to Psoriasis, who experienced unexpected, serious (medically significant) events of Foot fracture and Psoriasis (reported as Psoriasis flare-up), unspecified days after receiving a dose of mRNA-1273 vaccine as a third dose. Temporal association cannot be assessed due to lack of information regarding the date of vaccination.  Clinical course, work-ups done, and treatment details are not available in this report.  The outcome of the events was unknown.  The benefit-risk relationship of mRNA-1273 is not affected by this report.