Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Laboratory test, Off label use, Peripheral swelling, Rash erythematous
Clinical narrative: BURNING STOMACH; SINUSES; HEADACHE; MD INCREASED DOSING FREQUENCY TO 90MG EVERY 6 WEEKS; OFF LABEL USE; WITH RED RASH SPOTS ON BODY; CONTINUED TO HAVE CROHN'S SYMPTOMS; LEG SWELLING WITH COVID BOOSTER; This solicited report received from a health care professional concerned a 41 year adult male. Initial information was processed along with additional information received on 11-MAY-2022.  The patient's height, and weight were not reported. The patient's concurrent conditions included: crohns disease, and non-cancerous tumor (patient takes injection every 4 weeks to suppress non-cancerous tumors he has had for past 3 years). 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. (Dose number in series 1). The patient received combination product ustekinumab (Stelara) (solution for infusion, intravenous, batch number was not reported) dose and frequency were not reported from 2021, 90 mg, 1 time every 8 weeks, therapy dates were not reported, and 90 mg, 1 time every 6 weeks, from 25-FEB-2022 for crohn's disease which was off label use as Inappropriate schedule of product administration. The batch number was not reported and has been requested. 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 dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on FEB-2022 for prophylactic vaccination. Age at time of vaccination 41 years old. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2022, the patient reported that he continued to have Crohn's symptoms with stomach pain and visited the emergency room about 8 times since last year and was given medications, and tests (unspecified) were negative and also patient experienced leg swelling with covid booster and with red rash spots on body. The patient physician increased the dose of ustekinumab from 90 mg every 8 weeks to 90 mg every 6 weeks, patient reported that he has now done twice and feels better (Dose number in series 2). On APR-2022, the patient experienced headache and burning stomach. Physician did CT scan (computed tomography) and blood work which were negative. Physician thought it was may be sinuses and patient was advised to take ibuprofen and allergy medication for 2 weeks. Steroids were also prescribed for 2 months which patient finished (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ustekinumab was not changed. The patient recovered from leg swelling with covid booster and with red rash spots on body on 2022, was recovering from sinuses, had not recovered from continued to have crohn's symptoms, and the outcome of md increased dosing frequency to 90mg every 6 weeks, headache, burning stomach and off label use was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and continued to have crohn's symptoms, leg swelling with covid booster, burning stomach, md increased dosing frequency to 90mg every 6 weeks, and off label use was not related, and between covid-19 vaccine ad26.cov2.s, and with sinuses ,red rash spots on body and headache was related; and between ustekinumab, and continued to have crohn's symptoms, leg swelling with covid booster, burning stomach, sinuses, with red rash spots on body, md increased dosing frequency to 90mg every 6 weeks, and off label use was not related, and between ustekinumab, and headache was related. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20181015354. This report was associated with product quality complaint (PQC): 90000230280 The suspected product quality complaint has been confirmed to be not voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20220520084-covid-19 vaccine ad26.cov2.s-continued to have crohn's symptoms. The event(s) has an unknown/unclear 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: UNDERLYING DISEASE. Therefore, this event(s) is considered not related.  20220520084-ustekinumab (Stelara) -continued to have crohn's symptoms. This event(s) is labeled by standard procedures. Therefore, the event(s) is considered not related.