Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative
Clinical narrative: ULCERATIVE COLITIS FLARE UP / GOT A FLARE UP; This solicited report received from a consumer via PPSIMM000643: Regulatory Authority concerned a 76 year old female (number: 8037072) of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: ulcerative colitis. The patient was previously received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered (on an 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 (Dose number in series: 1). It was reported that, the patient was initially treated with ustekinumab (Stelara) (solution for infusion in pre-filled syringe, intravenous infusion) dose was not reported, administered on MAY-2021 for ulcerative colitis. Followed by, the patient initiated treatment with same drug ustekinumab (Stelara) (solution for infusion in pre-filled syringe, subcutaneous, batch number: 21A152MA and expiry: 31-MAY-2024) 90 mg, 1 time every 8 weeks, therapy dates were not reported, for ulcerative colitis. (The patient received last dose of ustekinumab (Stelara) on 06-JAN-2022).  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 covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on OCT-2021 (Date unspecified) 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. On OCT-2021 (Date unspecified), following vaccination with covid-19 vaccine ad26.cov2.s, the patient gradually started bleeding (Dose number in series: 2). The doctor told that, the patient got flare up which is coded as ulcerative colitis flare up (Dose number in series: 2). On DEC-2021 (Date unspecified), the bleeding got worse and was dripping. On 09-FEB-2022, the patient was started on oral steroids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ustekinumab (Stelara) was not changed. The patient was recovering from ulcerative colitis flare up / got a flare up. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and ulcerative colitis flare up / got a flare up was not related; and between ustekinumab, and ulcerative colitis flare up / got a flare up was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20220246585-covid-19 vaccine ad26.cov2.s-ulcerative colitis flare up / got a flare up.. 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, UNDERLYING DISEASE. Therefore, this event(s) is considered not related. (ulcerative colitis)   20220246585-Stelara (ustekinumab)-ulcerative colitis flare up / got a flare up. This event(s) is labeled by standard procedures. Therefore, the event(s) is considered not related.