Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incontinence, Injection site swelling, Malaise, Pyrexia, Rash
Clinical narrative: BLEEDING; EARLY DOSE; CLEARING OF MUCOUS; INCONTINENCE; ABDOMINAL CRAMPING; SENSITIVE TO FOOD; DEPRESSION; TACHYCARDIA RACING HEART 110 TO 140 BEATS PER MINUTE; DEHYDRATION; FLARE UP OF SYMPTOMS; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; MALAISE; GOT A RASH IRRITATION; INJECTION SITE SWELLING; HEADACHE; FEVERISH; This solicited report received from a consumer: Nurse Navigators from Janssen CarePath for STELARA Crohns concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously treated with hepatitis b vaccine for prophylactic vaccination, and varicella zoster vaccine for prophylactic vaccination.  The patient received combination product ustekinumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The drug was associated with Medication error. 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). On an unspecified date, the patient was previously treated with 3 doses of covid-19 vaccine (Dose number in series 1), from unspecified manufacturer (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine (Dose number in series 1). The patient initiated treatment with covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date patient experienced revaccination with different covid-19 vaccine following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). On an unspecified date, the patient was treated with non-company suspect vaccine included: covid-19 vaccine (unspecified manufacturer) (Dose number in series 3) (form of admin, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. Concomitant medications included ergocalciferol.  On an unspecified date, the patient experienced bleeding, early dose (patient reported she self-administered her fifth Stelara subcutaneous dose 1 day early), clearing of mucous, incontinence, abdominal cramping, sensitive to food, depression, tachycardia racing heart 110 to 140 beats per minute, dehydration, flare up of symptoms (increased symptoms within the first week), malaise, got a rash irritation may be due to sun exposure, injection site swelling, headache, and feverish following vaccination with covid-19 vaccine (unspecified manufacturer) (Dose number in series 3). Laboratory data (dates unspecified) included: Heart rate 110 to 140 beats per minute. The action taken with covid-19 vaccine ad26.cov2.s, and covid-19 vaccine was not applicable; dose of ustekinumab was not changed; and action taken with ustekinumab was not reported. The outcome of the early dose, injection site swelling, headache, clearing of mucous, incontinence, bleeding, malaise, abdominal cramping, sensitive to food, depression, feverish, tachycardia racing heart 110 to 140 beats per minute, got a rash irritation, dehydration, flare up of symptoms and revaccination with different covid-19 vaccine was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and bleeding, early dose, clearing of mucous, incontinence, abdominal cramping, sensitive to food, depression, tachycardia racing heart 110 to 140 beats per minute, dehydration, flare up of symptoms, and revaccination with different covid-19 vaccine was not related, and between covid-19 vaccine ad26.cov2.s, and malaise, got a rash irritation, injection site swelling, headache, and feverish was related; and between ustekinumab, and bleeding, early dose, clearing of mucous, incontinence, sensitive to food, tachycardia racing heart 110 to 140 beats per minute, dehydration, flare up of symptoms, revaccination with different covid-19 vaccine, malaise, abdominal cramping ,feverish and got a rash irritation was not related, and between ustekinumab, and depression, injection site swelling and headache  was related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220952662-covid-19 vaccine ad26.cov2.s-Bleeding. 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 not related.  20220952662-Stelara-Bleeding. 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 not related.