Sex: F
Vaccine: COVID19, UNK
Symptoms: Crohn's disease
Clinical narrative: CROHN'S DISEASE AGGRAVATED; This solicited report received from a patient through Reglority Authority via PPSIMM000646: SPP Fee For Service Sponosred Communication- Briova concerned a 62 year old female (patient number: 448466644) of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: crohn's disease with experiencing diarrhea. The patient was not pregnant at the time of vaccination. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1), (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1). The patient received combination product ustekinumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) 90 mg, frequency was not reported, from 17-JAN-2022 for crohn's disease. Product constituent parts included ultrasafe passive (route of admin, lot, serial number, model number, UDI number, and expiration were not reported); and ultrasafe passive accessory (route of admin, lot, serial number, model number, UDI number, and expiration were not reported). The patient received booster covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The patient experienced diarrhea due to her Crohn's disease, but noticed it was more frequent (crohn's disease aggravated) after receiving her booster vaccine and loading dose IV infusion on 17-JAN-2022 (Dose number in series 2). She also reported that she will receive her second maintenance dose of ustekinumab 1 week early due to traveling. Her doctor advised her to administer early to prevent the inconvenience of traveling and self administering ustekinumab while on vacation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ustekinumab was not changed. The outcome of crohn's disease aggravated was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and crohn's disease aggravated was not related; and between ustekinumab, and crohn's disease aggravated was not related.  This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220303594, 20220313580, 20220315935, 20220316005, 20220319093 and 20220319093.; Sender's Comments: V0: 20220322131-COVID-19 VACCINE AD26.COV2.S -Crohn's disease aggravated. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related. 20220322131-COVID-19 VACCINE AD26.COV2.S -Crohn's disease aggravated. This event(s) is labeled by standard procedures. Therefore, the event(s) is considered not related.