Sex: M
Vaccine: COVID19
Symptoms: Off label use, Therapeutic response shortened
Clinical narrative: WEARING OFF EFFECT; FELT BAD; OFF LABEL DOSE; ABDOMINAL PAIN; LEFT ARM LYMPH NODES SWOLLEN; BAD DIARRHEA; This solicited report received from a consumer via Regulatory Authority concerned an elderly male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: crohn's disease. Initial information was processed along with the additional information received on 18-NOV-2021. The patient received combination product ustekinumab (solution for injection in pre-filled syringe, subcutaneous, batch number: 21A142MB expiry: 30-APR-2021) 90 mg, 1 time every 6 weeks, therapy dates were not reported, and dose was not reported, 1 time every 8 weeks, from APR-2021 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 initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number were not reported and expiry: unknown) dose not reported, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch or lot number. No concomitant medications were reported. The patient said he was previously on Stelara every 8 weeks but his blood work showed Stelara was wearing off at the end (wearing off effect). Then his doctor of medicine (MD) had changed the frequency. On an unspecified date the patient started taking Stelara 90mg/1 ml for every 6 weeks (off label use) for his crohn's disease. It was also reported that the patient was not new to Stelara and he had not had a break in therapy from the last 60 days. Around the 6-week period having his symptoms of abdominal pain and bad diarrhea had come back. On an unspecified date, the patient also received covid vaccine and felt bad for about a day and he woke up in the middle of the night with his left arm lymph nodes swollen. After a day or so his lymph nodes returned to normal which his MD was not aware. Laboratory data (dates unspecified) included: Blood test (NR: not provided) stelara was wearing off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ustekinumab was not changed. The patient recovered from felt bad, and left arm lymph nodes swollen, and the outcome of off label dose, wearing off effect, abdominal pain and bad diarrhea was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and wearing off effect, and off label dose was not related, and between covid-19 vaccine ad26.cov2.s, and felt bad, abdominal pain, left arm lymph nodes swollen, and bad diarrhea was related; and between ustekinumab, and wearing off effect, felt bad, off label dose, abdominal pain, left arm lymph nodes swollen, and bad diarrhea was not related.  This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000202710 This case, from the same reporter is linked to 20180834308, 20181227012, 20121209473, 20200138277 and 20120508695.; Sender's Comments: V0- 20211140237- covid-19 vaccine ad26.cov2.s Wearing off effect. This event(s) is considered not related. 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: Special situation; CONMEDS-OTHER SUSPECT DRUGS 20211140237-ustekinumab  Wearing off effect This event(s) is labeled by standard procedures. The event(s) is considered not related.