Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fistula, Injury, Staphylococcal infection
Clinical narrative: FISTULAS; MRSA INFECTION; COVID INFECTION; INJURY; This spontaneous report received from a consumer (patient's parent) concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: Crohns disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose (dose number in series: 1), start therapy date were not reported for covid-19 prophylaxis. The patient received infliximab, recombinant (solution for infusion, intravenous drip, batch number was not reported) dose and frequency were not reported from 2008 for Crohn's disease. Non-company suspect drugs included: infliximab (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. Batch number was not reported and has been requested. No concomitant medications were reported.  It was reported patient was initially placed on REMICADE at age 12. Patient's prescriber has taken her off of REMICADE at intervals to try on different products, Inflectra being one of those products. As per reporter, patient had not developed antibodies to REMICADE and these intervals of switching from REMICADE  to another similar product has led to the patient forming fistulas (dose number in series: 1) that require inpatient hospital treatment. The patient has been back on REMICADE for one dose and was due for another dose on 20-MAY-2024, but the patient's insurance will lapse at the end of APR-2024. The reporter did not specify the nature of the Injury or reinjury, but did state that the reinjury prompted the discovery of a spreading MRSA infection (dose number in series: 1) that the patient acquired when she was hospitalized for the initial Injury. Patient was hospitalized for a week when this infection was found. There have been multiple hospitalizations over the course of the patient's disease and treatment with REMICADE. There were 3 hospital stays in 2023 - one stay for COVID infection (dose number in series: 1), one stay for Injury (dose number in series: 1), and one stay for reinjury wherein the MRSA infection was found. No further information was reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; dose of infliximab, and recombinant was not changed; and action taken with infliximab was not reported. The outcome of the fistulas, injury, MRSA infection and covid infection was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: COVID-19 Vaccine:  Staphylococcal infection, COVID-19, Fistula and Injury: The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable. Infliximab; Staphylococcal infection, COVID-19; This event(s) is labeled per Regulatory Agency and is therefore considered potentially related. Infliximab; Injury and Fistula : The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.